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

• ClinicalTrials.gov Identifier: NCT00489840
• Recruitment Status: Completed
• First Posted: June 21, 2007
• Last Update Posted: October 25, 2012
• Sponsor: Manhattan Eye, Ear & Throat Hospital
• Collaborators: LuEsther T. Mertz Retinal Research Center; Alcon Research
• Information provided by (Responsible Party): Joan, Manhattan Eye, Ear & Throat Hospital

Study Description

Brief Summary:

Investigation to evaluate Anecortave Acetate in the treatment of chronic central serous chorioretinopathy

Condition or disease	Intervention/treatment	Phase
Chronic Central Serous Chorioretinopathy	Drug: Anecortave Acetate Sterile suspension 15 mg; Drug: Anecortave Acetate	Phase 1; Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 5 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Treatment of Chronic Central Serous Chorioretinopathy With Open-label Anecortave Acetate
• Study Start Date: May 2007
• Actual Primary Completion Date: July 2010

Arms and Interventions

Arm	Intervention/treatment
Experimental: anecortave acetate	Drug: Anecortave Acetate Sterile suspension 15 mg; anecortave acetate sterile suspension 15 mg., juxtascleral injection, every 6 months. for 24 months; Other Name: retaane; Drug: Anecortave Acetate; anecortave acetate suspension 15 mg. juxtascleral injection every 6 months for 24 months.; Other Name: retaane

Outcome Measures

Primary Outcome Measures :

1. To investigate the use of Anecortave Acetate in patients with chronic central Chorioretinopathy [ Time Frame: 24 months ]

Secondary Outcome Measures :

1. •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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, New York

Manhattan Eye, ear & Throat Institute

New York, New York, United States, 10021

Vitreous-Retina-Macula Consultants of New York,PC

New York, New York, United States, 10022

Sponsors and Collaborators

Manhattan Eye, Ear & Throat Hospital

LuEsther T. Mertz Retinal Research Center

Alcon Research

Investigators

• Principal Investigator: Lawrence A. Yannuzzi, MD; Manhattan Eye, Ear & Throat Hospital

More Information

• Responsible Party: Joan, Lawrence A. Yannuzzi, M.D., Manhattan Eye, Ear & Throat Hospital
• ClinicalTrials.gov Identifier: NCT00489840
• Other Study ID Numbers: CSC-AA
• First Posted: June 21, 2007
• Last Update Posted: October 25, 2012
• Last Verified: October 2012

Keywords provided by Joan, Manhattan Eye, Ear & Throat Hospital:

Chronic Central Serous Chorioretinopathy

Additional relevant MeSH terms:

Central Serous Chorioretinopathy; Retinal Diseases; Eye Diseases; Hydrocortisone; Anecortave; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Physiological Effects of Drugs; Growth Inhibitors; Antineoplastic Agents; Anti-Inflammatory Agents