Trial Outcomes & Findings for Omega-3 Supplementation and Vitreal VEGF Levels in Wet-AMD (NCT NCT01819415)
NCT ID: NCT01819415
Last Updated: 2017-04-24
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
1 day (At the time of vitreous biopsy)
Results posted on
2017-04-24
Participant Flow
Recruitment dates: February-August 2011 Location: Maisonneuve-Rosemont Hospital, University of Montreal, Quebec, Canada
At least 3 months of no other treatments for wet-AMD in groups 1 and 2 and no treatment at all for group 3.
Participant milestones
| Measure |
Group 3 - Naive
Patients starting on intravitreal anti-VEGF treatment, not receiving Omega-3 supplements. They serve as wet-AMD controls.
|
Group 2 - Anti-VEGF Plus AREDS-1 Supplementation.
Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-1 plus Lutein supplementation formula.
|
Group 1 - Anti-VEGF Plus AREDS-2
Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-2 supplementation formula, that includes Omega-3 metabolites (DHA and EPA).
|
Group 4 - Control
Patients undergoing vitrectomy surgery for epiretinal membrane or macular hole had their vitreous samples to serve as controls.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
7
|
6
|
9
|
8
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Omega-3 Supplementation and Vitreal VEGF Levels in Wet-AMD
Baseline characteristics by cohort
| Measure |
Group 3 - Naive
n=10 Participants
Patients starting on intravitreal anti-VEGF treatment, not receiving Omega-3 supplements. They serve as wet-AMD controls.
|
Group 2 - Anti-VEGF Plus AREDS-1 Supplementation.
n=10 Participants
Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-1 plus Lutein supplementation formula.
|
Group 1 - Anti-VEGF Plus AREDS-2
n=10 Participants
Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-2 supplementation formula, that includes Omega-3 metabolites (DHA and EPA).
|
Group 4 - Control
n=10 Participants
Patients undergoing vitrectomy surgery for epiretinal membrane or macular hole had their vitreous samples to serve as controls.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
40 Participants
n=31 Participants
|
|
Age, Continuous
Age
|
83.38 years
STANDARD_DEVIATION 2.32 • n=99 Participants
|
79.00 years
STANDARD_DEVIATION 1.98 • n=107 Participants
|
79.6 years
STANDARD_DEVIATION 1.81 • n=206 Participants
|
68.25 years
STANDARD_DEVIATION 3.56 • n=7 Participants
|
77.56 years
STANDARD_DEVIATION 2.42 • n=31 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
20 Participants
n=31 Participants
|
|
Region of Enrollment
Canada
|
10 participants
n=99 Participants
|
10 participants
n=107 Participants
|
10 participants
n=206 Participants
|
10 participants
n=7 Participants
|
40 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 1 day (At the time of vitreous biopsy)Outcome measures
| Measure |
Group 3 - Naive
n=10 Participants
Patients starting on intravitreal anti-VEGF treatment, not receiving Omega-3 supplements. They serve as wet-AMD controls.
|
Group 2 - Anti-VEGF Plus AREDS-1 Supplementation.
n=10 Participants
Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-1 plus Lutein supplementation formula.
|
Group 1 - Anti-VEGF Plus AREDS-2
n=10 Participants
Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-2 supplementation formula, that includes Omega-3 metabolites (DHA and EPA).
|
Group 4 - Control
n=10 Participants
Patients undergoing vitrectomy surgery for epiretinal membrane or macular hole had their vitreous samples to serve as controls.
|
|---|---|---|---|---|
|
Vitreal VEGF Levels.
|
735.48 pg/ml
|
626.09 pg/ml
|
141.11 pg/ml
|
235.81 pg/ml
|
PRIMARY outcome
Timeframe: 1 day (At the time of vitreous biopsy)Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During at least 12 months of follow-up after vitreous biopsy.Measured with spectral-domain optical coherence tomography.
Outcome measures
Outcome data not reported
Adverse Events
Group 3 - Naive
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2 - Anti-VEGF Plus AREDS-1 Supplementation.
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 1 - Anti-VEGF Plus AREDS-2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 4 - Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place