Photodynamic Therapy Using Verteporfin for Treatment of Chronic Central Serous Chorioretinopathy (CSC)

This study has been completed.
Sponsor:
Information provided by:
Manhattan Eye, Ear & Throat Hospital
ClinicalTrials.gov Identifier:
NCT00211445
First received: September 13, 2005
Last updated: September 27, 2007
Last verified: September 2007
  Purpose

Central serous choroidal (CSC) retinopathy is a disease of the macula characterized by exudation of fluid under the retina localized to the posterior pole as well as loss of vision. The etiology is unknown, but according to the studies this condition is more common in young males and is associated with type A personality. Clinically, CSC is characterized by serous retinal detachment and area of leakage of in the subretinal space. 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, there is an indication for focal laser photocoagulation therapy of the area of leakage. This treatment is usually effective in stopping leakage of fluid under the retina and causing resolution of 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 RPE thus rendering laser treatment ineffective.The purpose of this medical research study is to evaluate Verteporfin therapy as an approach which may benefit patients with CSC, based on observations in exudative type of AMD patients treated with Photodynamic Therapy using Verteporfin.


Condition Intervention Phase
Chronic Central Serous Chorioretinopathy
Procedure: Photodynamic Therapy with Verteporfin
Drug: verteporfin
Drug: Verteporfin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Manhattan Eye, Ear & Throat Hospital:

Primary Outcome Measures:
  • mean change in VA (ETDRS) from baseline to 24 months [ Time Frame: 24 months ]
  • investigate the potential of photodynamic therapy using verteporpin in chronic central serous chorioretinopathy [ Time Frame: 24 months ]

Secondary Outcome Measures:
  • mean change of VA(ETDRS), OCT, FA from baseline to 24 months [ Time Frame: 2 years ]

Enrollment: 11
Study Start Date: July 2002
Study Completion Date: January 2006
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Evidence of chronic central serous chorioretinopathy and clinical/angiographic findings typical of the disease of greater than 6 months duration.Chronic central serous chorioretinopathy could be defined on the basis of two factors: a) persistence of the detachment for more than 6 months and b) chronic recurrent acute detachments with widespread decompensation of the retinal pigment epithelium.
  2. VA 20/40 and 20/320 Study Eye on the ETDRS visual acuity chart.
  3. VA 20/800 or better Fellow Eye on the ETDRS visual acuity chart.

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
  9. Age less than 18 years old
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00211445

Locations
United States, New York
Manhattan Eye, Ear & Throat Hospital
New York, New York, United States, 10021
Sponsors and Collaborators
Manhattan Eye, Ear & Throat Hospital
Investigators
Principal Investigator: Jason S. Slakter, MD Manhattan Eye, Ear & Throat Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00211445     History of Changes
Other Study ID Numbers: PDT for CSC
Study First Received: September 13, 2005
Last Updated: September 27, 2007
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Central Serous Chorioretinopathy
Retinal Diseases
Eye Diseases
Verteporfin
Photosensitizing Agents
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 28, 2014