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

NCT00489840 | Completed Phase 1

• 1 other identifier: CSC-AA
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Chronic Central Serous Chorioretinopathy

Keywords

Chronic Central Serous Chorioretinopathy

Outcome Measures

Primary Outcomes (1)

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

  24 months

Secondary Outcomes (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

  24 months

Study Arms (1)

anecortave acetate

EXPERIMENTAL

Drug: Anecortave Acetate Sterile suspension 15 mg; Drug: Anecortave Acetate

Interventions

Anecortave Acetate Sterile suspension 15 mg DRUG

anecortave acetate sterile suspension 15 mg., juxtascleral injection, every 6 months. for 24 months

Also known as: retaane

anecortave acetate

Anecortave Acetate DRUG

anecortave acetate suspension 15 mg. juxtascleral injection every 6 months for 24 months.

Also known as: retaane

anecortave acetate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Manhattan Eye, Ear & Throat Hospital: lead
• LuEsther T. Mertz Retinal Research Center: collaborator
• Alcon Research: collaborator

Study Sites (2)

Manhattan Eye, ear & Throat Institute

New York, New York, 10021, United States

Location

Vitreous-Retina-Macula Consultants of New York,PC

New York, New York, 10022, United States

Location

MeSH Terms

Interventions

anecortave acetate

Study Officials

• Lawrence A. Yannuzzi, MD

  Manhattan Eye, Ear & Throat Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lawrence A. Yannuzzi, M.D.

Study Record Dates

• First Submitted: June 20, 2007
• First Posted: June 21, 2007
• Study Start: May 1, 2007
• Primary Completion: July 1, 2010
• Last Updated: October 25, 2012

Record last verified: 2012-10

Locations

US (2)