Intravitreal Aflibercept Injection for Persistent Central Serous Chorioretinopathy: A Prospective Pilot Study
Overview
- Phase
- Phase 2
- Intervention
- Intravitreal Aflibercept Injection
- Conditions
- Central Serous Chorioretinopathy
- Sponsor
- Wills Eye
- Enrollment
- 12
- Locations
- 2
- Primary Endpoint
- Safety of Intravitreal Aflibercept Injection
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
A preliminary study to determine the safety and efficacy of intravitreal aflibercept injection in patients with persistent central serous chorioretinopathy.
Detailed Description
Intravitreal Aflibercept Injection for Persistent Central Serous Chorioretinopathy: A Prospective Pilot Study
Investigators
Allen C. Ho, MD
Investigator
Wills Eye
Eligibility Criteria
Inclusion Criteria
- •Pre-treatment acuity of 20/40- 20/320
- •Macular fluid on optical coherence tomography for greater than 3 months
- •Leakage on fluorescein angiography
- •Willing and able to comply with clinic visits and study-related procedures
- •Provide signed informed consent
Exclusion Criteria
- •Treatment for CSCR in the study eye (anti-VEGF, PDT, or laser) within three months prior to study enrollment
- •Presence of choroidal neovascularization on enrollment imaging
- •Prior vitrectomy in the study eye
- •Presence of any substantial ocular disease (other than CSCR) that may compromise vision in the study eye and /or confound interpretation of the data; e.g. substantial cataracts, advanced glaucoma, optic neuritis, optic neuropathy or atrophy, marked macular atrophy, ocular vascular occlusion, history of retinal detachment, uveitis, viral or other forms of chorioretinitis, etc.
- •History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye
- •Uncontrolled glaucoma in the study eye (defined as IOP ≥ 25 mmHg despite treatment with anti-glaucoma medication)
- •Active ocular infection or inflammation in the study eye
- •Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
- •Prior treatment with systemic anti-VEGF agents
- •Cerebrovascular accident or myocardial infarction within the preceding 6 months.
Arms & Interventions
Intravitreal Aflibercept Injection (x4)
2 mg / Intravitreal / every 1 month x 3 months and at month 4 (Drug administered 4 times).
Intervention: Intravitreal Aflibercept Injection
Intravitreal Aflibercept Injection (x6)
2 mg / Intravitreal / every 1 month x 6 months ((Drug administered 6 times).
Intervention: Intravitreal Aflibercept Injection
Outcomes
Primary Outcomes
Safety of Intravitreal Aflibercept Injection
Time Frame: 6 months
Safety will be measured by the amount, significance and details of adverse events/reactions to the study drug.
Secondary Outcomes
- Change in Vision Based on Letter Score(6 months)