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

Study Overview
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Brief Summary
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A preliminary study to determine the safety and efficacy of intravitreal aflibercept injection in patients with persistent central serous chorioretinopathy.

Detailed Description
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Intravitreal Aflibercept Injection for Persistent Central Serous Chorioretinopathy: A Prospective Pilot Study

Official Title
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Intravitreal Aflibercept Injection for Persistent Central Serous Chorioretinopathy: A Prospective Pilot Study

Conditions
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Central Serous Chorioretinopathy

Intervention / Treatment
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* Drug: Intravitreal Aflibercept Injection


Participation Criteria
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Eligibility Criteria
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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. History of allergy to fluorescein, povidone iodine (Betadine) or aflibercept Participation in a study of an investigational drug or device within 30 days prior to potential enrollment into the study Pregnant or breast-feeding women Sexually active men* or women of childbearing potential** who are unwilling to practice adequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device [IUD]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly) Contraception is not required for men with documented vasectomy. Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of child bearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intravitreal Aflibercept Injection (x4)<br>2 mg / Intravitreal / every 1 month x 3 months and at month 4 (Drug administered 4 times). | Drug: Intravitreal Aflibercept Injection<br>* 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).<br>* Other names: Eylea;|
| Experimental: Intravitreal Aflibercept Injection (x6)<br>2 mg / Intravitreal / every 1 month x 6 months ((Drug administered 6 times). | Drug: Intravitreal Aflibercept Injection<br>* 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).<br>* Other names: Eylea;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of Intravitreal Aflibercept Injection | Safety will be measured by the amount, significance and details of adverse events/reactions to the study drug. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Vision Based on Letter Score | • Mean change from baseline in best-corrected ETDRS (Early Treatment of Diabetic Retinopathy Study) letter score | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Persistent, Central, Serous, Chorioretinopathy, Regeneron, CSR, CSCR