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

NCT00211445 | Completed Phase 2

• 1 other identifier: PDT for CSC
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Central Serous Chorioretinopathy

Outcome Measures

Primary Outcomes (2)

• mean change in VA (ETDRS) from baseline to 24 months

  24 months

• investigate the potential of photodynamic therapy using verteporpin in chronic central serous chorioretinopathy

  24 months

Secondary Outcomes (1)

• mean change of VA(ETDRS), OCT, FA from baseline to 24 months

  2 years

Interventions

Photodynamic Therapy with Verteporfin PROCEDURE

verteporfin DRUG

Eligibility Criteria

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

You may qualify if:

• 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.
• VA 20/40 and 20/320 Study Eye on the ETDRS visual acuity chart.
• VA 20/800 or better Fellow Eye on the ETDRS visual acuity chart.

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
• Age less than 18 years old

Sponsors & Collaborators

• Manhattan Eye, Ear & Throat Hospital: lead

Study Sites (1)

Manhattan Eye, Ear & Throat Hospital

New York, New York, 10021, United States

Location

MeSH Terms

Interventions

Photochemotherapy; Verteporfin

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy; Porphyrins; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Jason S. Slakter, MD

  Manhattan Eye, Ear & Throat Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: July 1, 2002
• Study Completion: January 1, 2006
• Last Updated: September 28, 2007

Record last verified: 2007-09

Locations

US (1)