Status:
COMPLETED
Intravitreal Ranibizumab Treatment of Central Serous Chorioretinopathy
Lead Sponsor:
Vitreous -Retina- Macula Consultants of New York
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Central Serous Chorioretinopathy
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
The purpose of this study is to examine the effects of Lucentis for active Central Serous Chorioretinopathy.
Detailed Description
This is an open-label, Phase I study of intravitreally administered ranibizumab in subjects with unresolving CSC and subfoveal fluid. Patients will be evaluated at baseline with ophthalmic examination...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00403325
Start Date
August 1 2006
Last Update
November 3 2008
Active Locations (1)
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1
Vitreous Retina Macula Consultants of New York, P.C.
New York, New York, United States, 10022