Intravitreal Ranibizumab Treatment of Central Serous Chorioretinopathy

Completed · Phase 1

Conditions studied: Central Serous Chorioretinopathy

In brief

The purpose of this study is to examine the effects of Lucentis for active Central Serous Chorioretinopathy.

Key facts

Study ID

NCT00403325

Run by

Vitreous -Retina- Macula Consultants of New York

People needed

9

Starts

2006-08-01

Last updated by the study team

2008-11-03

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• A history of persistent central serous chorioretinopathy present for at least 3 months Best-corrected visual acuity (BCVA) of 20/40 (73 letters on the ETDRS chart) to light perception as measured by ETDRS protocol refraction.
• No signs of choroidal neovascularization
• Documented subfoveal fluid by OCT
• Active leak associated with the subfoveal fluid
• The ability and willingness to provide written informed consent

You may not qualify if…

• Prior treatment with laser or PDT
• Have uncontrolled hypertension
• Have a history of thromboembolic events including stroke, transient ischemic attacks, and myocardial infarction
• Have use of or need for continued anticoagulation therapy, except aspirin 325 mg/day.
• Are receiving or require chronic concomitant therapy with systemic (> 5 mg) or topical ocular corticosteroids. Chronic concomitant therapy is defined as multiple doses taken daily for 14 or more consecutive days at any time within 6 months prior to screening
• Previously vitrectomized eyes.
• Had allergic reactions to fluorescein dye or lack of venous access.
• Any other additional ocular diseases which could irreversibly compromise the visual acuity of the study eye including amblyopia, anterior ischemic optic neuropathy (AION), age related macular degeneration (AMD), retinal detachment, severe cataracts, etc.
• An anticipated need for ocular surgery during the duration of the trial.
• Within 1 month prior to screening, have had intra ocular surgeries (including cataract surgery) in the study eye.
• Intravitreal triamcinolone or bevacizumab in the previous 2 months
• Uncontrolled glaucoma (IOP > 24 mmHg) on greater than 3 medications.
• Within 1 month prior to screening had YAG laser capsulotomy in the study eye
• Have received any other systemic experimental drug within 12 weeks prior to enrollment.
• Rubeosis iridis or neovascular glaucoma
• Any untreated rhegmatogenous retinal detachment.
• A visual acuity of worse than 20/400 in the fellow eye.
• Unwilling or unable to follow or comply with all study related procedures.

Where it is running

• Vitreous Retina Macula Consultants of New York, P.C. — New York, New York, United States

Full record on ClinicalTrials.gov

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