Trial Outcomes & Findings for The Safety & Efficacy of Intravitreal Aflibercept Injection in Patients With Persistent Central Serous Chorioretinopathy (NCT NCT01710332)

Results Overview

Safety will be measured by the amount, significance and details of adverse events/reactions to the study drug.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

12 participants

Primary outcome timeframe

6 months

Results posted on

2017-06-16

Participant Flow

Participant milestones

Participant milestones
Measure	Intravitreal Aflibercept Injection (x4) 2 mg / Intravitreal / every 1 month x 3 months and at month 4 (Drug administered 4 times). Intravitreal Aflibercept Injection: GROUP A - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, and Month 4 (four injections total). GROUP B - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, Month 3, Month 4, and Month 5 (six injections total).	Intravitreal Aflibercept Injection (x6) 2 mg / Intravitreal / every 1 month x 6 months ((Drug administered 6 times). Intravitreal Aflibercept Injection: GROUP A - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, and Month 4 (four injections total). GROUP B - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, Month 3, Month 4, and Month 5 (six injections total).
Overall Study STARTED	6	6
Overall Study COMPLETED	6	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Safety & Efficacy of Intravitreal Aflibercept Injection in Patients With Persistent Central Serous Chorioretinopathy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intravitreal Aflibercept Injection (x4) n=6 Participants 2 mg / Intravitreal / every 1 month x 3 months and at month 4 (Drug administered 4 times). Intravitreal Aflibercept Injection: GROUP A - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, and Month 4 (four injections total). GROUP B - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, Month 3, Month 4, and Month 5 (six injections total).	Intravitreal Aflibercept Injection (x6) n=6 Participants 2 mg / Intravitreal / every 1 month x 6 months ((Drug administered 6 times). Intravitreal Aflibercept Injection: GROUP A - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, and Month 4 (four injections total). GROUP B - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, Month 3, Month 4, and Month 5 (six injections total).	Total n=12 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	53.8 years STANDARD_DEVIATION 12.8 • n=5 Participants	53.5 years STANDARD_DEVIATION 9.6 • n=7 Participants	53.7 years STANDARD_DEVIATION 10.8 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment United States	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Safety will be measured by the amount, significance and details of adverse events/reactions to the study drug.

Outcome measures

Outcome measures
Measure	Intravitreal Aflibercept Injection (x4) n=6 Participants 2 mg / Intravitreal / every 1 month x 3 months and at month 4 (Drug administered 4 times). Intravitreal Aflibercept Injection: GROUP A - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, and Month 4 (four injections total).	Intravitreal Aflibercept Injection (x6) n=6 Participants 2 mg / Intravitreal / every 1 month x 6 months ((Drug administered 6 times). GROUP B - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, Month 3, Month 4, and Month 5 (six injections total).
Safety of Intravitreal Aflibercept Injection	0 adverse events	0 adverse events

SECONDARY outcome

Timeframe: 6 months

• Mean change from baseline in best-corrected ETDRS (Early Treatment of Diabetic Retinopathy Study) letter score

Outcome measures

Outcome measures
Measure	Intravitreal Aflibercept Injection (x4) n=6 Participants 2 mg / Intravitreal / every 1 month x 3 months and at month 4 (Drug administered 4 times). Intravitreal Aflibercept Injection: GROUP A - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, and Month 4 (four injections total).	Intravitreal Aflibercept Injection (x6) n=6 Participants 2 mg / Intravitreal / every 1 month x 6 months ((Drug administered 6 times). GROUP B - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, Month 3, Month 4, and Month 5 (six injections total).
Change in Vision Based on Letter Score	-0.3 ETDRS letters Standard Deviation 12.4	4.7 ETDRS letters Standard Deviation 13.4

Adverse Events

Intravitreal Aflibercept Injection (x4)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intravitreal Aflibercept Injection (x6)

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

Allen C. Ho, MD

Mid Atlantic Retina

Phone: 215-459-0477

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place