Intravitreal Ranibizumab Treatment of Central Serous Chorioretinopathy

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Brief Title

Intravitreal Ranibizumab Treatment of Central Serous Chorioretinopathy

Official Title

Phase I Study of Intravitreally Administered Ranibizumab in Subjects With Unresolving CSC and Subfoveal Fluid.

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, fluorescein angiography, optical coherence tomography, and color
      photography. Subjects will receive open-label intravitreal injections of 0.5 mg ranibizumab
      administered every 28 days (± 2 days) for 3 injections. Thereafter they are to be evaluated
      every month until month 12. Treatment will be administered to patients if there is presence
      of active leakage as determined by fluorescein angiography or persistence presence of sub
      retinal fluid upon OCT examination at that monthly visit.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

To determine the safety and tolerability of 0.5 mg dose of Ranibizumab in the treatment of chronic central serous retinopathy (CSC)

Secondary Outcome

 Mean change in VA compared to baseline at month 6 and month 12

Condition

Central Serous Chorioretinopathy

Intervention

rhuFab V2 [ranibizumab] ( Lucentis )


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

9

Start Date

August 2006



Eligibility Criteria

        Inclusion Criteria:

          -  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 Criteria:

          -  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.
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Richard F. Spaide, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00403325

Organization ID

FVF3850S



Study Sponsor

Vitreous -Retina- Macula Consultants of New York

Collaborators

 Genentech, Inc.

Study Sponsor

Richard F. Spaide, M.D., Principal Investigator, Vitreous Retina Macula Consultants of New York, P.C.


Verification Date

October 2008