Trial Outcomes & Findings for Minocycline to Treat Central Retinal Vein Occlusion (NCT NCT01468844)
NCT ID: NCT01468844
Last Updated: 2021-03-17
Results Overview
The primary outcome measure is the mean change in best-corrected visual acuity (BCVA), as measured in ETDRS letters in the study eye at 12 months compared to baseline. Values presented represent mean and standard deviation of change from baseline at 12 months.
COMPLETED
PHASE1/PHASE2
6 participants
Baseline to Month 12
2021-03-17
Participant Flow
Participant milestones
| Measure |
Minocycline
Participants injected with bevacizumab for three months followed by PRN dosing and 100mg minocycline twice daily for 24 months
Minocycline: 100 mg pink opaque capsule
|
Placebo
Participants injected with bevacizumab for three months followed by PRN dosing and placebo twice daily for 24 months
Placebo: Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
2
|
|
Overall Study
COMPLETED
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Minocycline
Participants injected with bevacizumab for three months followed by PRN dosing and 100mg minocycline twice daily for 24 months
Minocycline: 100 mg pink opaque capsule
|
Placebo
Participants injected with bevacizumab for three months followed by PRN dosing and placebo twice daily for 24 months
Placebo: Placebo
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Minocycline to Treat Central Retinal Vein Occlusion
Baseline characteristics by cohort
| Measure |
Minocycline
n=4 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and 100mg minocycline twice daily for 24 months
Minocycline: 100 mg pink opaque capsule
|
Placebo
n=2 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and placebo twice daily for 24 months
Placebo: Placebo
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
|
Age, Continuous
|
71.0 years
STANDARD_DEVIATION 8.8 • n=39 Participants
|
66.0 years
STANDARD_DEVIATION 11.1 • n=41 Participants
|
69.3 years
STANDARD_DEVIATION 8.8 • n=35 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Baseline to Month 12Population: The primary outcome analysis population includes those participants who were exposed to IP and were followed up for at least 12 months. One participant in the minocycline group was excluded from the analysis because their Month 12 data was not recorded due to their withdrawal from the study prior to Month 12, and one participant in the placebo group was excluded due to missing ETDRS BCVA letters data at baseline.
The primary outcome measure is the mean change in best-corrected visual acuity (BCVA), as measured in ETDRS letters in the study eye at 12 months compared to baseline. Values presented represent mean and standard deviation of change from baseline at 12 months.
Outcome measures
| Measure |
Minocycline
n=3 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and 100mg minocycline twice daily for 24 months.
Minocycline: 100 mg pink opaque capsule
Bevacizumab: 1.25 mg bevacizumab injection
|
Placebo
n=1 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and placebo twice daily for 24 months.
Placebo: Placebo
Bevacizumab: 1.25 mg bevacizumab injection
|
|---|---|---|
|
The Primary Outcome is the Comparison Between the Minocycline and Placebo Groups of the Mean Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at 12 Months Compared to Baseline.
|
13.3 ETDRS letters
Standard Deviation 7.0
|
-2.0 ETDRS letters
Standard Deviation NA
There was only one participant analyzed for the primary outcome in the placebo group, so standard deviation could not be calculated.
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: The secondary outcomes are based on the safety population, which includes all participants who were exposed to IP, regardless of adherence to protocol. One participant in the minocycline group was excluded from the analysis because their Month 12 data was not recorded due to their withdrawal from the study prior to Month 12.
Improvement of ≥ 1 logOCT scale step is defined as a decrease of ≥ 1-step on the logOCT scale. A 1-step decrease is equivalent to at least a 20% improvement of central macular thickness.
Outcome measures
| Measure |
Minocycline
n=3 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and 100mg minocycline twice daily for 24 months.
Minocycline: 100 mg pink opaque capsule
Bevacizumab: 1.25 mg bevacizumab injection
|
Placebo
n=2 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and placebo twice daily for 24 months.
Placebo: Placebo
Bevacizumab: 1.25 mg bevacizumab injection
|
|---|---|---|
|
Number of Participants Improving ≥ 1 logOCT Scale Step in the Study Eye at 12 Months Compared to Baseline
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline to Month 24Population: The secondary outcomes are based on the safety population, which includes all participants who were exposed to IP, regardless of adherence to protocol. Two participants in the minocycline group were excluded because their Month 24 data was not recorded due to their withdrawal from the study prior to Month 24.
Improvement of ≥ 1 logOCT scale step is defined as a decrease of ≥ 1-step on the logOCT scale. A 1-step decrease is equivalent to at least a 20% improvement of central macular thickness.
Outcome measures
| Measure |
Minocycline
n=2 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and 100mg minocycline twice daily for 24 months.
Minocycline: 100 mg pink opaque capsule
Bevacizumab: 1.25 mg bevacizumab injection
|
Placebo
n=2 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and placebo twice daily for 24 months.
Placebo: Placebo
Bevacizumab: 1.25 mg bevacizumab injection
|
|---|---|---|
|
Number of Participants Improving ≥ 1 logOCT Scale Step in the Study Eye at 24 Months Compared to Baseline
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: The secondary outcomes are based on the safety population, which includes all participants who were exposed to IP, regardless of adherence to protocol.
The outcome measure is the number of bevacizumab injections administered to participants between baseline and 12 months.
Outcome measures
| Measure |
Minocycline
n=4 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and 100mg minocycline twice daily for 24 months.
Minocycline: 100 mg pink opaque capsule
Bevacizumab: 1.25 mg bevacizumab injection
|
Placebo
n=2 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and placebo twice daily for 24 months.
Placebo: Placebo
Bevacizumab: 1.25 mg bevacizumab injection
|
|---|---|---|
|
Number of Bevacizumab Injections From Baseline to 12 Months
|
5.5 injections
Standard Deviation 4.4
|
10.5 injections
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Baseline to Month 24Population: The secondary outcomes are based on the safety population, which includes all participants who were exposed to IP, regardless of adherence to protocol.
The outcome measure is the number of bevacizumab injections administered to participants between baseline and 24 months.
Outcome measures
| Measure |
Minocycline
n=4 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and 100mg minocycline twice daily for 24 months.
Minocycline: 100 mg pink opaque capsule
Bevacizumab: 1.25 mg bevacizumab injection
|
Placebo
n=2 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and placebo twice daily for 24 months.
Placebo: Placebo
Bevacizumab: 1.25 mg bevacizumab injection
|
|---|---|---|
|
Number of Bevacizumab Injections From Baseline to 24 Months
|
7.8 injections
Standard Deviation 8.8
|
16.0 injections
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: Baseline to Month 3Population: The secondary outcomes are based on the safety population, which includes all participants who were exposed to IP, regardless of adherence to protocol. One participant in the minocycline group was excluded due to missing macular sensitivity data at Month 3.
The outcome measure is the mean change in macular sensitivity in the study eye at 3 months compared to baseline. Values presented represent mean and standard deviation of change from baseline at 3 months.
Outcome measures
| Measure |
Minocycline
n=3 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and 100mg minocycline twice daily for 24 months.
Minocycline: 100 mg pink opaque capsule
Bevacizumab: 1.25 mg bevacizumab injection
|
Placebo
n=2 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and placebo twice daily for 24 months.
Placebo: Placebo
Bevacizumab: 1.25 mg bevacizumab injection
|
|---|---|---|
|
Changes in Mean Macular Sensitivity in the Study Eye as Measured by Microperimetry at 3 Months Compared to Baseline
|
0.8 db
Standard Deviation 2.2
|
3.4 db
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: Baseline to Month 6Population: The secondary outcomes are based on the safety population, which includes all participants who were exposed to IP, regardless of adherence to protocol. One participant in the minocycline group was excluded from the analysis because their Month 6 data was not recorded due to withdrawal from the study prior to Month 6.
The outcome measure is the mean change in macular sensitivity in the study eye at 6 months compared to baseline. Values presented represent mean and standard deviation of change from baseline at 6 months.
Outcome measures
| Measure |
Minocycline
n=3 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and 100mg minocycline twice daily for 24 months.
Minocycline: 100 mg pink opaque capsule
Bevacizumab: 1.25 mg bevacizumab injection
|
Placebo
n=2 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and placebo twice daily for 24 months.
Placebo: Placebo
Bevacizumab: 1.25 mg bevacizumab injection
|
|---|---|---|
|
Changes in Mean Macular Sensitivity in the Study Eye as Measured by Microperimetry at 6 Months Compared to Baseline
|
0.3 db
Standard Deviation 2.8
|
1.1 db
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: The secondary outcomes are based on the safety population, which includes all participants who were exposed to IP, regardless of adherence to protocol. One participant in the minocycline group was excluded from the analysis because their Month 12 data was not recorded due to withdrawal from the study prior to Month 12.
The outcome measure is the mean change in macular sensitivity in the study eye at 12 months compared to baseline. Values presented represent mean and standard deviation of change from baseline at 12 months.
Outcome measures
| Measure |
Minocycline
n=3 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and 100mg minocycline twice daily for 24 months.
Minocycline: 100 mg pink opaque capsule
Bevacizumab: 1.25 mg bevacizumab injection
|
Placebo
n=2 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and placebo twice daily for 24 months.
Placebo: Placebo
Bevacizumab: 1.25 mg bevacizumab injection
|
|---|---|---|
|
Changes in Mean Macular Sensitivity in the Study Eye as Measured by Microperimetry at 12 Months Compared to Baseline
|
-1.7 db
Standard Deviation 5.5
|
1.3 db
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Baseline to Month 18Population: The secondary outcomes are based on the safety population, which includes all participants who were exposed to IP, regardless of adherence to protocol. Two participants in the minocycline group were excluded from the analysis because their Month 18 data was not recorded due to withdrawal from the study prior to Month 18.
The outcome measure is the mean change in macular sensitivity in the study eye at 18 months compared to baseline. Values presented represent mean and standard deviation of change from baseline at 18 months.
Outcome measures
| Measure |
Minocycline
n=2 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and 100mg minocycline twice daily for 24 months.
Minocycline: 100 mg pink opaque capsule
Bevacizumab: 1.25 mg bevacizumab injection
|
Placebo
n=2 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and placebo twice daily for 24 months.
Placebo: Placebo
Bevacizumab: 1.25 mg bevacizumab injection
|
|---|---|---|
|
Changes in Mean Macular Sensitivity in the Study Eye as Measured by Microperimetry at 18 Months Compared to Baseline
|
-0.9 db
Standard Deviation 4.0
|
4.5 db
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: Baseline to Month 24Population: The secondary outcomes are based on the safety population, which includes all participants who were exposed to IP, regardless of adherence to protocol. Two participants in the minocycline group were excluded from the analysis because their Month 24 data was not recorded due to withdrawal from the study prior to Month 24.
The outcome measure is the mean change in macular sensitivity in the study eye at 24 months compared to baseline. Values presented represent mean and standard deviation of change from baseline at 24 months.
Outcome measures
| Measure |
Minocycline
n=2 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and 100mg minocycline twice daily for 24 months.
Minocycline: 100 mg pink opaque capsule
Bevacizumab: 1.25 mg bevacizumab injection
|
Placebo
n=2 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and placebo twice daily for 24 months.
Placebo: Placebo
Bevacizumab: 1.25 mg bevacizumab injection
|
|---|---|---|
|
Changes in Mean Macular Sensitivity in the Study Eye as Measured by Microperimetry at 24 Months Compared to Baseline
|
-1.5 db
Standard Deviation 3.3
|
3.9 db
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: Baseline to Month 24Population: The secondary outcomes are based on the safety population, which includes all participants who were exposed to IP, regardless of adherence to protocol. Two participants in the minocycline group were excluded from the analysis because their Month 24 data was not recorded due to withdrawal from the study prior to Month 24, and one participant in the placebo group was excluded due to missing baseline BCVA data.
The outcome measure is the mean change in best-corrected visual acuity (BCVA), as measured in ETDRS letters in the study eye at 24 months compared to baseline. Values presented represent mean and standard deviation of change from baseline at 24 months.
Outcome measures
| Measure |
Minocycline
n=2 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and 100mg minocycline twice daily for 24 months.
Minocycline: 100 mg pink opaque capsule
Bevacizumab: 1.25 mg bevacizumab injection
|
Placebo
n=1 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and placebo twice daily for 24 months.
Placebo: Placebo
Bevacizumab: 1.25 mg bevacizumab injection
|
|---|---|---|
|
Mean Change in the ETDRS BCVA in the Study Eye at 24 Months Compared to Baseline
|
13 ETDRS letters
Standard Deviation 0.0
|
-17.0 ETDRS letters
Standard Deviation NA
There was only one participant analyzed in the placebo group, so standard deviation could not be calculated.
|
SECONDARY outcome
Timeframe: Baseline to Month 6Population: The secondary outcomes are based on the safety population, which includes all participants who were exposed to IP, regardless of adherence to protocol. One participant in the minocycline group was excluded from the analysis because their Month 6 data was not recorded due to withdrawal from the study prior to Month 6.
The outcome measure is the mean change in central retinal thickness in the study eye at 6 months compared to baseline. Values presented represent mean and standard deviation of change from baseline at 6 months.
Outcome measures
| Measure |
Minocycline
n=3 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and 100mg minocycline twice daily for 24 months.
Minocycline: 100 mg pink opaque capsule
Bevacizumab: 1.25 mg bevacizumab injection
|
Placebo
n=2 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and placebo twice daily for 24 months.
Placebo: Placebo
Bevacizumab: 1.25 mg bevacizumab injection
|
|---|---|---|
|
Changes in Retinal Thickness in the Study Eye as Measured by Optical Coherence Tomography (OCT) at 6 Months Compared to Baseline
|
-272.7 micrometers
Standard Deviation 117.0
|
-312.0 micrometers
Standard Deviation 128.7
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: The secondary outcomes are based on the safety population, which includes all participants who were exposed to IP, regardless of adherence to protocol. One participant in the minocycline group was excluded from the analysis because their Month 12 data was not recorded due to withdrawal from the study prior to Month 12.
The outcome measure is the mean change in central retinal thickness in the study eye at 12 months compared to baseline. Values presented represent mean and standard deviation of change from baseline at 12 months.
Outcome measures
| Measure |
Minocycline
n=3 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and 100mg minocycline twice daily for 24 months.
Minocycline: 100 mg pink opaque capsule
Bevacizumab: 1.25 mg bevacizumab injection
|
Placebo
n=2 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and placebo twice daily for 24 months.
Placebo: Placebo
Bevacizumab: 1.25 mg bevacizumab injection
|
|---|---|---|
|
Changes in Retinal Thickness in the Study Eye as Measured by Optical Coherence Tomography (OCT) at 12 Months Compared to Baseline
|
-145.3 micrometers
Standard Deviation 259.1
|
-458.5 micrometers
Standard Deviation 313.2
|
SECONDARY outcome
Timeframe: Baseline to Month 18Population: The secondary outcomes are based on the safety population, which includes all participants who were exposed to IP, regardless of adherence to protocol. Two participants in the minocycline group were excluded from the analysis because their Month 18 data was not recorded due to withdrawal from the study prior to Month 18.
The outcome measure is the difference in the mean change in central retinal thickness in the study eye at 18 months compared to baseline. Values presented represent mean and standard deviation of change from baseline at 18 months.
Outcome measures
| Measure |
Minocycline
n=2 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and 100mg minocycline twice daily for 24 months.
Minocycline: 100 mg pink opaque capsule
Bevacizumab: 1.25 mg bevacizumab injection
|
Placebo
n=2 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and placebo twice daily for 24 months.
Placebo: Placebo
Bevacizumab: 1.25 mg bevacizumab injection
|
|---|---|---|
|
Changes in Retinal Thickness in the Study Eye as Measured by Optical Coherence Tomography (OCT) at 18 Months Compared to Baseline
|
-52.0 micrometers
Standard Deviation 169.7
|
-480.5 micrometers
Standard Deviation 118.1
|
SECONDARY outcome
Timeframe: Baseline to Month 24Population: The secondary outcomes are based on the safety population, which includes all participants who were exposed to IP, regardless of adherence to protocol. Two participants in the minocycline group were excluded from the analysis because their Month 24 data was not recorded due to withdrawal from the study prior to Month 24.
The outcome measure is the mean change in central retinal thickness in the study eye at 24 months compared to baseline. Values presented represent mean and standard deviation of change from baseline at 24 months.
Outcome measures
| Measure |
Minocycline
n=2 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and 100mg minocycline twice daily for 24 months.
Minocycline: 100 mg pink opaque capsule
Bevacizumab: 1.25 mg bevacizumab injection
|
Placebo
n=2 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and placebo twice daily for 24 months.
Placebo: Placebo
Bevacizumab: 1.25 mg bevacizumab injection
|
|---|---|---|
|
Changes in Retinal Thickness in the Study Eye as Measured by Optical Coherence Tomography (OCT) at 24 Months Compared to Baseline
|
-227.0 micrometers
Standard Deviation 84.9
|
-346.0 micrometers
Standard Deviation 41.0
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: The secondary outcomes are based on the safety population, which includes all participants who were exposed to IP, regardless of adherence to protocol. Two participants in the minocycline group were excluded from the analysis: one because their Month 12 data was not recorded due to withdrawal from the study prior to Month 12, and one due to missing data for fluid leakage at the Month 12 visit.
The outcome measure is the number of participants experiencing changes in fluid leakage in the macula of the study eye as demonstrated by fluorescein angiography at 12 months compared to baseline. The counts presented are the number of participants experiencing decrease, increase, or no change in fluid leakage from baseline.
Outcome measures
| Measure |
Minocycline
n=2 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and 100mg minocycline twice daily for 24 months.
Minocycline: 100 mg pink opaque capsule
Bevacizumab: 1.25 mg bevacizumab injection
|
Placebo
n=2 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and placebo twice daily for 24 months.
Placebo: Placebo
Bevacizumab: 1.25 mg bevacizumab injection
|
|---|---|---|
|
Changes in Fluid Leakage in the Macula of the Study Eye as Demonstrated by Fluorescein Angiography at 12 Months Compared to Baseline
Decrease
|
2 participants
|
1 participants
|
|
Changes in Fluid Leakage in the Macula of the Study Eye as Demonstrated by Fluorescein Angiography at 12 Months Compared to Baseline
Increase
|
0 participants
|
1 participants
|
|
Changes in Fluid Leakage in the Macula of the Study Eye as Demonstrated by Fluorescein Angiography at 12 Months Compared to Baseline
No Change
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline to Month 24Population: The secondary outcomes are based on the safety population, which includes all participants who were exposed to IP, regardless of adherence to protocol. Two participants in the minocycline group were excluded from the analysis because their Month 24 data was not recorded due to withdrawal from the study prior to Month 24, and one participant in the placebo group was excluded due to missing data for fluid leakage at the Month 24 visit.
The outcome measure is the the number of participants experiencing changes in fluid leakage in the macula of the study eye as demonstrated by fluorescein angiography at 24 months compared to baseline. The counts presented are the number of participants experiencing decrease, increase, or no change in fluid leakage from baseline.
Outcome measures
| Measure |
Minocycline
n=2 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and 100mg minocycline twice daily for 24 months.
Minocycline: 100 mg pink opaque capsule
Bevacizumab: 1.25 mg bevacizumab injection
|
Placebo
n=1 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and placebo twice daily for 24 months.
Placebo: Placebo
Bevacizumab: 1.25 mg bevacizumab injection
|
|---|---|---|
|
Changes in Fluid Leakage in the Macula of the Study Eye as Demonstrated by Fluorescein Angiography at 24 Months Compared to Baseline.
Decrease
|
2 participants
|
1 participants
|
|
Changes in Fluid Leakage in the Macula of the Study Eye as Demonstrated by Fluorescein Angiography at 24 Months Compared to Baseline.
Increase
|
0 participants
|
0 participants
|
|
Changes in Fluid Leakage in the Macula of the Study Eye as Demonstrated by Fluorescein Angiography at 24 Months Compared to Baseline.
No Change
|
0 participants
|
0 participants
|
Adverse Events
Minocycline
Placebo
Serious adverse events
| Measure |
Minocycline
n=4 participants at risk
Participants injected with bevacizumab for three months followed by PRN dosing and 100mg minocycline twice daily for 24 months
Minocycline: 100 mg pink opaque capsule
|
Placebo
n=2 participants at risk
Participants injected with bevacizumab for three months followed by PRN dosing and placebo twice daily for 24 months
Placebo: Placebo
|
|---|---|---|
|
Infections and infestations
Klebsiella bacteraemia
|
25.0%
1/4 • Number of events 1 • 24 months
|
0.00%
0/2 • 24 months
|
|
General disorders
Systemic inflammatory response syndrome
|
25.0%
1/4 • Number of events 1 • 24 months
|
0.00%
0/2 • 24 months
|
|
Nervous system disorders
Cerebellar artery thrombosis
|
0.00%
0/4 • 24 months
|
50.0%
1/2 • Number of events 1 • 24 months
|
Other adverse events
| Measure |
Minocycline
n=4 participants at risk
Participants injected with bevacizumab for three months followed by PRN dosing and 100mg minocycline twice daily for 24 months
Minocycline: 100 mg pink opaque capsule
|
Placebo
n=2 participants at risk
Participants injected with bevacizumab for three months followed by PRN dosing and placebo twice daily for 24 months
Placebo: Placebo
|
|---|---|---|
|
Eye disorders
Punctate keratitis
|
50.0%
2/4 • Number of events 4 • 24 months
|
0.00%
0/2 • 24 months
|
|
Eye disorders
Conjunctival haemorrhage
|
25.0%
1/4 • Number of events 1 • 24 months
|
50.0%
1/2 • Number of events 2 • 24 months
|
|
Eye disorders
Diplopia
|
25.0%
1/4 • Number of events 2 • 24 months
|
0.00%
0/2 • 24 months
|
|
Eye disorders
Angle closure glaucoma
|
25.0%
1/4 • Number of events 1 • 24 months
|
0.00%
0/2 • 24 months
|
|
Eye disorders
Blepharitis
|
0.00%
0/4 • 24 months
|
50.0%
1/2 • Number of events 1 • 24 months
|
|
Eye disorders
Eye pain
|
25.0%
1/4 • Number of events 1 • 24 months
|
0.00%
0/2 • 24 months
|
|
Eye disorders
Eyelid ptosis
|
25.0%
1/4 • Number of events 1 • 24 months
|
0.00%
0/2 • 24 months
|
|
Eye disorders
Macular fibrosis
|
25.0%
1/4 • Number of events 1 • 24 months
|
0.00%
0/2 • 24 months
|
|
Eye disorders
Vitreous haemorrhage
|
25.0%
1/4 • Number of events 1 • 24 months
|
0.00%
0/2 • 24 months
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
1/4 • Number of events 1 • 24 months
|
50.0%
1/2 • Number of events 1 • 24 months
|
|
Investigations
Blood pressure increased
|
25.0%
1/4 • Number of events 1 • 24 months
|
0.00%
0/2 • 24 months
|
|
Investigations
Blood thyroid stimulating hormone abnormal
|
25.0%
1/4 • Number of events 1 • 24 months
|
0.00%
0/2 • 24 months
|
|
Investigations
Blood thyroid stimulating hormone increased
|
25.0%
1/4 • Number of events 1 • 24 months
|
0.00%
0/2 • 24 months
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/4 • 24 months
|
50.0%
1/2 • Number of events 1 • 24 months
|
|
Investigations
International normalised ratio decreased
|
25.0%
1/4 • Number of events 1 • 24 months
|
0.00%
0/2 • 24 months
|
|
Investigations
International normalised ratio increased
|
25.0%
1/4 • Number of events 1 • 24 months
|
0.00%
0/2 • 24 months
|
|
Investigations
Liver function test increased
|
25.0%
1/4 • Number of events 1 • 24 months
|
0.00%
0/2 • 24 months
|
|
Investigations
Prostatic specific antigen increased
|
0.00%
0/4 • 24 months
|
50.0%
1/2 • Number of events 1 • 24 months
|
|
Investigations
Renal function test abnormal
|
25.0%
1/4 • Number of events 1 • 24 months
|
0.00%
0/2 • 24 months
|
|
Investigations
Transaminases increased
|
25.0%
1/4 • Number of events 1 • 24 months
|
0.00%
0/2 • 24 months
|
|
Infections and infestations
Nasopharyngitis
|
25.0%
1/4 • Number of events 1 • 24 months
|
100.0%
2/2 • Number of events 3 • 24 months
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/4 • 24 months
|
50.0%
1/2 • Number of events 2 • 24 months
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/4 • 24 months
|
50.0%
1/2 • Number of events 1 • 24 months
|
|
Infections and infestations
Influenza
|
0.00%
0/4 • 24 months
|
50.0%
1/2 • Number of events 1 • 24 months
|
|
Infections and infestations
Respiratory tract infection
|
25.0%
1/4 • Number of events 1 • 24 months
|
0.00%
0/2 • 24 months
|
|
Infections and infestations
Sinusitis
|
25.0%
1/4 • Number of events 1 • 24 months
|
0.00%
0/2 • 24 months
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Number of events 4 • 24 months
|
0.00%
0/2 • 24 months
|
|
Gastrointestinal disorders
Abdominal discomfort
|
25.0%
1/4 • Number of events 1 • 24 months
|
50.0%
1/2 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • 24 months
|
50.0%
1/2 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • Number of events 1 • 24 months
|
0.00%
0/2 • 24 months
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
1/4 • Number of events 1 • 24 months
|
0.00%
0/2 • 24 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • 24 months
|
50.0%
1/2 • Number of events 1 • 24 months
|
|
Nervous system disorders
Dizziness
|
25.0%
1/4 • Number of events 1 • 24 months
|
100.0%
2/2 • Number of events 2 • 24 months
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/4 • 24 months
|
50.0%
1/2 • Number of events 1 • 24 months
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • 24 months
|
50.0%
1/2 • Number of events 1 • 24 months
|
|
Nervous system disorders
Tension headache
|
0.00%
0/4 • 24 months
|
50.0%
1/2 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
25.0%
1/4 • Number of events 1 • 24 months
|
0.00%
0/2 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
25.0%
1/4 • Number of events 1 • 24 months
|
0.00%
0/2 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
25.0%
1/4 • Number of events 1 • 24 months
|
0.00%
0/2 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • 24 months
|
50.0%
1/2 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/4 • 24 months
|
50.0%
1/2 • Number of events 1 • 24 months
|
|
General disorders
Fatigue
|
50.0%
2/4 • Number of events 2 • 24 months
|
0.00%
0/2 • 24 months
|
|
General disorders
Oedema peripheral
|
25.0%
1/4 • Number of events 1 • 24 months
|
0.00%
0/2 • 24 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
2/4 • Number of events 2 • 24 months
|
0.00%
0/2 • 24 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
25.0%
1/4 • Number of events 1 • 24 months
|
0.00%
0/2 • 24 months
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
25.0%
1/4 • Number of events 1 • 24 months
|
0.00%
0/2 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
25.0%
1/4 • Number of events 2 • 24 months
|
0.00%
0/2 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • 24 months
|
50.0%
1/2 • Number of events 1 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/4 • 24 months
|
50.0%
1/2 • Number of events 1 • 24 months
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
75.0%
3/4 • Number of events 3 • 24 months
|
0.00%
0/2 • 24 months
|
|
Cardiac disorders
Acute myocardial infarction
|
25.0%
1/4 • Number of events 1 • 24 months
|
0.00%
0/2 • 24 months
|
|
Endocrine disorders
Hypothyroidism
|
25.0%
1/4 • Number of events 1 • 24 months
|
0.00%
0/2 • 24 months
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/4 • 24 months
|
50.0%
1/2 • Number of events 1 • 24 months
|
|
Renal and urinary disorders
Nephrolithiasis
|
25.0%
1/4 • Number of events 1 • 24 months
|
0.00%
0/2 • 24 months
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/4 • 24 months
|
50.0%
1/2 • Number of events 1 • 24 months
|
|
Surgical and medical procedures
Sinus operation
|
25.0%
1/4 • Number of events 1 • 24 months
|
0.00%
0/2 • 24 months
|
|
Eye disorders
Retinal pigmentation
|
25.0%
1/4 • Number of events 1 • 24 months
|
0.00%
0/2 • 24 months
|
Additional Information
Catherine Cukras, MD, PhD, Principal Investigator, NEI
National Institutes of Health
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place