Trial Outcomes & Findings for 20089 TA+Lucentis Combo Intravitreal Injections for Treatment of Neovascular Age-related Macular Degeneration (AMD) (NCT NCT01175395)
NCT ID: NCT01175395
Last Updated: 2014-10-20
Results Overview
The primary objective is to assess the ocular safety of 20089 TA (6.9 mg or 13.8 mg)treatment in combination with Lucentis. The ocular safety endpoints to be assessed include the number of participants with ocular Adverse Events such as: evidence of endophthalmitis, uveitis, ocular hemorrhage, retinal tear or detachment to be assessed during ophthalmic examinations. Elevated IOP as measured by an applanation tonometer at every visit.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
10 participants
Primary outcome timeframe
360 Days
Results posted on
2014-10-20
Participant Flow
Patients were recruited from Sept 2010 to January 2012.
Participant milestones
| Measure |
IBI-20089/Lucentis
Alternate treatment of either 6.9 mg IBI-20089/Lucentis or 13.8 mg IBI-20089/Lucentis
IBI-20089/Lucentis : Combining a single dose of IBI-20089 (6.9 mg or 13.8 mg) intravitreal injection adjunctively with Lucentis 0.5 mg intravitreal injection at baseline and monthly intravitreal Lucentis injection PRN based on clinical and OCT results.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
20089 TA+Lucentis Combo Intravitreal Injections for Treatment of Neovascular Age-related Macular Degeneration (AMD)
Baseline characteristics by cohort
| Measure |
IBI-20089/Lucentis
n=10 Participants
Alternate treatment of either 6.9 mg IBI-20089/Lucentis or 13.8 mg IBI-20089/Lucentis
IBI-20089/Lucentis : Combining a single dose of IBI-20089 (6.9 mg or 13.8 mg) intravitreal injection adjunctively with Lucentis 0.5 mg intravitreal injection at baseline and monthly intravitreal Lucentis injection PRN based on clinical and OCT results.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 360 DaysThe primary objective is to assess the ocular safety of 20089 TA (6.9 mg or 13.8 mg)treatment in combination with Lucentis. The ocular safety endpoints to be assessed include the number of participants with ocular Adverse Events such as: evidence of endophthalmitis, uveitis, ocular hemorrhage, retinal tear or detachment to be assessed during ophthalmic examinations. Elevated IOP as measured by an applanation tonometer at every visit.
Outcome measures
| Measure |
IBI-20089/Lucentis
n=10 Participants
Alternate treatment of either 6.9 mg IBI-20089/Lucentis or 13.8 mg IBI-20089/Lucentis
IBI-20089/Lucentis : Combining a single dose of IBI-20089 (6.9 mg or 13.8 mg) intravitreal injection adjunctively with Lucentis 0.5 mg intravitreal injection at baseline and monthly intravitreal Lucentis injection PRN based on clinical and OCT results.
|
|---|---|
|
To Assess the Safety & Tolerability of 20089 TA (6.9 mg or 13.8 mg) When Used Adjunctively With Lucentis 0.5 mg in Subjects With Sub-foveal Neovascular AMD
|
0 Number-participants with adverse events
|
SECONDARY outcome
Timeframe: 30 to 360 daysBecause of the combination - 20089/Lucentis - treatment, patients may not require monthly Lucentis injections as is the current standard of care practice for AMD.
Outcome measures
| Measure |
IBI-20089/Lucentis
n=10 Participants
Alternate treatment of either 6.9 mg IBI-20089/Lucentis or 13.8 mg IBI-20089/Lucentis
IBI-20089/Lucentis : Combining a single dose of IBI-20089 (6.9 mg or 13.8 mg) intravitreal injection adjunctively with Lucentis 0.5 mg intravitreal injection at baseline and monthly intravitreal Lucentis injection PRN based on clinical and OCT results.
|
|---|---|
|
To Determine the Number of Retreatments With Lucentis in Eyes Initially Treated With 20089 TA and Lucentis
|
2 retreatments
Interval 0.0 to 6.0
|
Adverse Events
IBI-20089/Lucentis
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IBI-20089/Lucentis
n=10 participants at risk
Alternate treatment of either 6.9 mg IBI-20089/Lucentis or 13.8 mg IBI-20089/Lucentis
IBI-20089/Lucentis : Combining a single dose of IBI-20089 (6.9 mg or 13.8 mg) intravitreal injection adjunctively with Lucentis 0.5 mg intravitreal injection at baseline and monthly intravitreal Lucentis injection PRN based on clinical and OCT results.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
fracture of sacrum
|
10.0%
1/10 • Number of events 1 • 1 year
Number of subjects who developed progression of cataract Number of subjects with intraocular pressure (IOP) elevation above 25 mmHg Number of subjects with any severe ocular adverse event Number of subjects with any severe systemic adverse event
|
Other adverse events
| Measure |
IBI-20089/Lucentis
n=10 participants at risk
Alternate treatment of either 6.9 mg IBI-20089/Lucentis or 13.8 mg IBI-20089/Lucentis
IBI-20089/Lucentis : Combining a single dose of IBI-20089 (6.9 mg or 13.8 mg) intravitreal injection adjunctively with Lucentis 0.5 mg intravitreal injection at baseline and monthly intravitreal Lucentis injection PRN based on clinical and OCT results.
|
|---|---|
|
Eye disorders
ocular hypertension
|
70.0%
7/10 • Number of events 7 • 1 year
Number of subjects who developed progression of cataract Number of subjects with intraocular pressure (IOP) elevation above 25 mmHg Number of subjects with any severe ocular adverse event Number of subjects with any severe systemic adverse event
|
|
Eye disorders
subconjunctival hemorrhage
|
50.0%
5/10 • Number of events 6 • 1 year
Number of subjects who developed progression of cataract Number of subjects with intraocular pressure (IOP) elevation above 25 mmHg Number of subjects with any severe ocular adverse event Number of subjects with any severe systemic adverse event
|
|
Eye disorders
cataract surgery
|
10.0%
1/10 • Number of events 1 • 1 year
Number of subjects who developed progression of cataract Number of subjects with intraocular pressure (IOP) elevation above 25 mmHg Number of subjects with any severe ocular adverse event Number of subjects with any severe systemic adverse event
|
|
Eye disorders
vitreous floaters
|
10.0%
1/10 • Number of events 1 • 1 year
Number of subjects who developed progression of cataract Number of subjects with intraocular pressure (IOP) elevation above 25 mmHg Number of subjects with any severe ocular adverse event Number of subjects with any severe systemic adverse event
|
|
Eye disorders
temporal pallor of optic nerve
|
10.0%
1/10 • Number of events 1 • 1 year
Number of subjects who developed progression of cataract Number of subjects with intraocular pressure (IOP) elevation above 25 mmHg Number of subjects with any severe ocular adverse event Number of subjects with any severe systemic adverse event
|
|
Eye disorders
posterior vitreous detachment
|
20.0%
2/10 • Number of events 2 • 1 year
Number of subjects who developed progression of cataract Number of subjects with intraocular pressure (IOP) elevation above 25 mmHg Number of subjects with any severe ocular adverse event Number of subjects with any severe systemic adverse event
|
|
Eye disorders
retinal hemorrhage
|
10.0%
1/10 • Number of events 1 • 1 year
Number of subjects who developed progression of cataract Number of subjects with intraocular pressure (IOP) elevation above 25 mmHg Number of subjects with any severe ocular adverse event Number of subjects with any severe systemic adverse event
|
|
Reproductive system and breast disorders
infective vaginitis
|
10.0%
1/10 • Number of events 1 • 1 year
Number of subjects who developed progression of cataract Number of subjects with intraocular pressure (IOP) elevation above 25 mmHg Number of subjects with any severe ocular adverse event Number of subjects with any severe systemic adverse event
|
|
Eye disorders
ptosis of eyelid
|
10.0%
1/10 • Number of events 1 • 1 year
Number of subjects who developed progression of cataract Number of subjects with intraocular pressure (IOP) elevation above 25 mmHg Number of subjects with any severe ocular adverse event Number of subjects with any severe systemic adverse event
|
|
Gastrointestinal disorders
food poisoning
|
10.0%
1/10 • Number of events 1 • 1 year
Number of subjects who developed progression of cataract Number of subjects with intraocular pressure (IOP) elevation above 25 mmHg Number of subjects with any severe ocular adverse event Number of subjects with any severe systemic adverse event
|
|
Psychiatric disorders
anxiety
|
10.0%
1/10 • Number of events 1 • 1 year
Number of subjects who developed progression of cataract Number of subjects with intraocular pressure (IOP) elevation above 25 mmHg Number of subjects with any severe ocular adverse event Number of subjects with any severe systemic adverse event
|
|
Eye disorders
watery eye
|
10.0%
1/10 • Number of events 1 • 1 year
Number of subjects who developed progression of cataract Number of subjects with intraocular pressure (IOP) elevation above 25 mmHg Number of subjects with any severe ocular adverse event Number of subjects with any severe systemic adverse event
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place