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Treatment of Chronic Central Serous Chorioretinopathy With Open-Label Anecortave Acetate (CSC-AA)

Primary Purpose

Chronic Central Serous Chorioretinopathy

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Anecortave Acetate Sterile suspension 15 mg
Anecortave Acetate
Sponsored by
Manhattan Eye, Ear & Throat Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. A male or female, of any race with clinical signs of chronic CSC:Evidence of chronic central serous chorioretinopathy and clinical/angiographic findings typical of the disease of greater than 6 months duration. Chronic central serous chorioretinopathy can be defined on the basis of two factors: 1) persistence of the detachment for more than 6 months and 2) chronic recurrent acute detachments with widespread decompensation of the retinal pigment epithelium
  2. Patient must have best corrected ETDRS visual acuity between 20/40 and 20/320 in the Study Eye and visual acuity of 20/800 or better Fellow Eye
  3. Patient must be willing, able to comply with the protocol, and provide informed consent.

Exclusion Criteria:

  1. Patient with tears in retinal pigment epithelium.
  2. Patient with significantly compromised visual acuity in the study eye due to concomitant ocular conditions.
  3. Patients who have undergone intraocular surgery within last 2 months or capsulotomy within last month in study eye
  4. Patient participating in any other investigational drug study.
  5. Inability to obtain photographs to document CNV (including difficulty with venous access)
  6. Patient with significant liver disease or uremia.
  7. Patient with known adverse reaction to indocyanine green or iodine.
  8. Patient is pregnant or nursing.

Sites / Locations

  • Manhattan Eye, ear & Throat Institute
  • Vitreous-Retina-Macula Consultants of New York,PC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

anecortave acetate

Arm Description

Outcomes

Primary Outcome Measures

To investigate the use of Anecortave Acetate in patients with chronic central Chorioretinopathy

Secondary Outcome Measures

•Mean change in ETDRS Visual Acuity at 4 meters compared to baseline •Mean change in central retinal thickness as measured by OCT . -Change in leakage area seen during fluorescein angiography and ICG

Full Information

First Posted
June 20, 2007
Last Updated
October 24, 2012
Sponsor
Manhattan Eye, Ear & Throat Hospital
Collaborators
LuEsther T. Mertz Retinal Research Center, Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT00489840
Brief Title
Treatment of Chronic Central Serous Chorioretinopathy With Open-Label Anecortave Acetate
Acronym
CSC-AA
Official Title
Treatment of Chronic Central Serous Chorioretinopathy With Open-label Anecortave Acetate
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Manhattan Eye, Ear & Throat Hospital
Collaborators
LuEsther T. Mertz Retinal Research Center, Alcon Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Investigation to evaluate Anecortave Acetate in the treatment of chronic central serous chorioretinopathy
Detailed Description
Central serous chorioretinopathy (CSC) is a disease of the macula characterized by loss of vision from exudation of fluid under the retina localized to the posterior pole. Acute central serous chorioretinopathy (CSC) has been defined as an idiopathic detachment of the neurosensory retina in the macular region associated with a focal leak at the level of the retinal pigment epithelium on fluorescein angiography. This area of leakage usually corresponds to a defect in retinal pigment epithelium (RPE). An acute episode of CSC usually resolves within 3 months from the time of onset with almost total restoration of the visual acuity. However, in a more severe form of the disease, chronic central serous chorioretinopathy, there is diffuse decompensation of the RPE, recurrent retinal detachments, and progressive loss of visual acuity. Indocyanine green angiography shows diffuse hyperpermeability of the choriocapillaris layer. This chronic form of CSC is usually bilateral, and often causes severe vision loss and impaired quality of life for the patient. Chronic central serous chorioretinopathy can be defined on the basis of two factors: 1) persistence of the detachment for more than 6 months and 2) chronic recurrent acute detachments with widespread decompensation of the retinal pigment epithelium. The standard of care for acute CSC is observation for a period of up to 3 months. If there is no complete resolution of the retinal detachment by 3 months, focal laser photocoagulation therapy may be used to treat the area of leakage. This treatment is usually effective in stopping leakage of fluid under the retina and causing resolution of the detachment. However, laser photocoagulation therapy is not beneficial in the treatment of chronic CSC because there is not a single easily identifiable point of leakage but rather diffuse disease of the RPE, thus rendering laser treatment ineffective. Because of the limitations of laser photocoagulation for chronic CSC, other treatments are currently under evaluation. Corticosteroids appear to be intimately related to the pathogenesis of the disease. Exogenous corticosteroids have been shown to induce the disease via a variety of routes, whether oral, intravenous, intranasal, or intraarticular. Secondly, patients with endogenous hypercortisolism, such as those with Cushing's syndrome or with a type A personality, are also at increased risk of developing the disease. The purpose of this medical research study is to evaluate Anecortave Acetate as an approach which may benefit patients with chronic CSC. Anecortave acetate is a novel agent, derived from the steroid cortisone, but modified to eliminate glucocorticoid effects via removal of the 11β-hydroxyl group, addition of a double bond at C9-11, and addition of an acetate group at C21 to increase ocular penetration and stability. Anecortave acetate has recently been shown to possess anti-glucocorticoid effects in the eye, such as in blocking steroid-induced glaucoma. Anecortave acetate treatment to the eye has been evaluated for other disorders, such as macular degneration, and boasts an outstanding safety record, with no adverse systemic reactions. Ocular adverse events were mild, such as subconjunctival hemorrhage. The concept of this protocol is that if Anecortave Acetate blocks the steroid receptors for glaucoma and prevents steroid-induced glaucoma, perhaps it blocks the the steroid induced receptors involved in the pathogenesis of central serous chorioretinopathy. If successful, this modality of treatment may reduce the risk of progressive visual damage due to chronic CSC and perhaps even improve visual function without causing destruction to the overlying neurosensory retina.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
anecortave acetate
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Anecortave Acetate Sterile suspension 15 mg
Other Intervention Name(s)
retaane
Intervention Description
anecortave acetate sterile suspension 15 mg., juxtascleral injection, every 6 months. for 24 months
Intervention Type
Drug
Intervention Name(s)
Anecortave Acetate
Other Intervention Name(s)
retaane
Intervention Description
anecortave acetate suspension 15 mg. juxtascleral injection every 6 months for 24 months.
Primary Outcome Measure Information:
Title
To investigate the use of Anecortave Acetate in patients with chronic central Chorioretinopathy
Time Frame
24 months
Secondary Outcome Measure Information:
Title
•Mean change in ETDRS Visual Acuity at 4 meters compared to baseline •Mean change in central retinal thickness as measured by OCT . -Change in leakage area seen during fluorescein angiography and ICG
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A male or female, of any race with clinical signs of chronic CSC:Evidence of chronic central serous chorioretinopathy and clinical/angiographic findings typical of the disease of greater than 6 months duration. Chronic central serous chorioretinopathy can be defined on the basis of two factors: 1) persistence of the detachment for more than 6 months and 2) chronic recurrent acute detachments with widespread decompensation of the retinal pigment epithelium Patient must have best corrected ETDRS visual acuity between 20/40 and 20/320 in the Study Eye and visual acuity of 20/800 or better Fellow Eye Patient must be willing, able to comply with the protocol, and provide informed consent. Exclusion Criteria: Patient with tears in retinal pigment epithelium. Patient with significantly compromised visual acuity in the study eye due to concomitant ocular conditions. Patients who have undergone intraocular surgery within last 2 months or capsulotomy within last month in study eye Patient participating in any other investigational drug study. Inability to obtain photographs to document CNV (including difficulty with venous access) Patient with significant liver disease or uremia. Patient with known adverse reaction to indocyanine green or iodine. Patient is pregnant or nursing.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence A. Yannuzzi, MD
Organizational Affiliation
Manhattan Eye, Ear & Throat Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Manhattan Eye, ear & Throat Institute
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Vitreous-Retina-Macula Consultants of New York,PC
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States

12. IPD Sharing Statement

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Treatment of Chronic Central Serous Chorioretinopathy With Open-Label Anecortave Acetate

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