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Clinical Trials/NCT01710332
NCT01710332
Completed
Phase 2

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

Wills Eye2 sites in 1 country12 target enrollmentOctober 2012

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

Registry
clinicaltrials.gov
Start Date
October 2012
End Date
June 2013
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Wills Eye
Responsible Party
Principal Investigator
Principal Investigator

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)

Study Sites (2)

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