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Intravitreal Ranibizumab Treatment of Central Serous Chorioretinopathy

Primary Purpose

Central Serous Chorioretinopathy

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
rhuFab V2 [ranibizumab] ( Lucentis )
Sponsored by
Vitreous -Retina- Macula Consultants of New York
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Central Serous Chorioretinopathy focused on measuring Central Serous Chorioretinopathy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Mean change in VA compared to baseline at month 6 and month 12
Proportion of patients with 20/20 vision at month 6 and 12 as compared to baseline
Proportion of patients losing ≤ 15 letters as measured by ETDRS visual refraction at 4 meters compared to baseline at month 6 and 12
Proportion of patients gaining ≥ 15 letters as measured by ETDRS visual refraction at 4 meters compared to baseline at month 6 and 12
Change in subretinal fluid (as measured by optical coherence tomography) from baseline at month 3, 6, 9 and 12

Full Information

First Posted
November 22, 2006
Last Updated
October 31, 2008
Sponsor
Vitreous -Retina- Macula Consultants of New York
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00403325
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Vitreous -Retina- Macula Consultants of New York
Collaborators
Genentech, Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Serous Chorioretinopathy
Keywords
Central Serous Chorioretinopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
rhuFab V2 [ranibizumab] ( Lucentis )
Primary Outcome Measure Information:
Title
To determine the safety and tolerability of 0.5 mg dose of Ranibizumab in the treatment of chronic central serous retinopathy (CSC)
Secondary Outcome Measure Information:
Title
Mean change in VA compared to baseline at month 6 and month 12
Title
Proportion of patients with 20/20 vision at month 6 and 12 as compared to baseline
Title
Proportion of patients losing ≤ 15 letters as measured by ETDRS visual refraction at 4 meters compared to baseline at month 6 and 12
Title
Proportion of patients gaining ≥ 15 letters as measured by ETDRS visual refraction at 4 meters compared to baseline at month 6 and 12
Title
Change in subretinal fluid (as measured by optical coherence tomography) from baseline at month 3, 6, 9 and 12

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard F. Spaide, M.D.
Organizational Affiliation
Vitreous Retina Macula Consultants of New York, P.C.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vitreous Retina Macula Consultants of New York, P.C.
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Intravitreal Ranibizumab Treatment of Central Serous Chorioretinopathy

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