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

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Brief Title

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

Official Title

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

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.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 •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

Condition

Chronic Central Serous Chorioretinopathy

Intervention

Anecortave Acetate Sterile suspension 15 mg

Study Arms / Comparison Groups

 anecortave acetate
Description:  

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

5

Start Date

May 2007


Primary Completion Date

July 2010

Eligibility 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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Lawrence A. Yannuzzi, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00489840

Organization ID

CSC-AA


Responsible Party

Principal Investigator

Study Sponsor

Manhattan Eye, Ear & Throat Hospital

Collaborators

 LuEsther T. Mertz Retinal Research Center

Study Sponsor

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


Verification Date

October 2012