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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 12

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravitreal Aflibercept Injection (x4)	Intravitreal Aflibercept Injection	2 mg / Intravitreal / every 1 month x 3 months and at month 4 (Drug administered 4 times).
Intravitreal Aflibercept Injection (x6)	Intravitreal Aflibercept Injection	2 mg / Intravitreal / every 1 month x 6 months ((Drug administered 6 times).

Primary Outcome Measures

Name	Time	Method
Safety of Intravitreal Aflibercept Injection	6 months	Safety will be measured by the amount, significance and details of adverse events/reactions to the study drug.

Secondary Outcome Measures

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

Trial Locations

Locations (2): Mid Atlantic Retna- Wills Eye Institute
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Philadelphia, Pennsylvania, United States
Mid Atlantic Retina- Huntingdon Valley
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Huntingdon Valley, Pennsylvania, United States