Overview

This trial is active, not recruiting.

Condition central serous chorioretinopathy
Treatment intravitreal aflibercept injection
Phase phase 2
Sponsor Wills Eye
Collaborator Regeneron Pharmaceuticals
Start date October 2012
End date June 2013
Trial size 12 participants
Trial identifier NCT01710332, 20121564, CSRII

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
2 mg / Intravitreal / every 1 month x 3 months and at month 4 (Drug administered 4 times).
intravitreal aflibercept injection Eylea
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).
(Experimental)
2 mg / Intravitreal / every 1 month x 6 months ((Drug administered 6 times).
intravitreal aflibercept injection Eylea
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).

Primary Outcomes

Measure
Safety of intravitreal aflibercept injection
time frame: 6 months

Secondary Outcomes

Measure
Change in vision based on letter score
time frame: 6 months

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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.

Additional Information

Official title Intravitreal Aflibercept Injection for Persistent Central Serous Chorioretinopathy: A Prospective Pilot Study
Principal investigator Allen Ho, MD
Description Intravitreal Aflibercept Injection for Persistent Central Serous Chorioretinopathy: A Prospective Pilot Study
Trial information was received from ClinicalTrials.gov and was last updated in June 2013.
Information provided to ClinicalTrials.gov by Wills Eye.