ICG-Guided Photodynamic Therapy for Treatment of Retinal Capillary Abnormalities: A Pilot Study

Not Applicable

• Conditions: Retinal Vascular Disorders
• Interventions: Drug: Visudyne

• Registration Number: NCT01974622
• Lead Sponsor: Manhattan Eye, Ear & Throat Hospital

Brief Summary

The purpose of this research is to use an approved drug(Visudyne) for neovascular age-related macular degeneration, which is essentially choroidal neovascularization for permeability and vascular proliferation for the retinal circulation, to treat another permeable abnormality - retinal capillary abnormalities - located eccentric to the central portion of the macula or in the foveal region.

Detailed Description

The study will include 30 patients who were diagnosed with retinal capillary abnormalities and include 2 follow-up visits at 6 and 12 months post-procedure to determine if the treatment has been effective in treating their disorder. It is anticipated that approximately half of the patients will require an additional treatment. Patients will be enrolled from our patient population and be 50 years of age and older, male or female. Pregnant women or women of normal child bearing age will be excluded since there are no adequate and well-controlled studies on the use of photodynamic therapy in pregnant women. Any retinal vascular abnormality that has a standard of care method of treatment will also be excluded from the study population.

Study Timeline

• Study Start: 2013-04
• Status Verified: 2013-10
• Study First Submitted: 2013-10-28
• Study First Submitted QC: 2013-10-28
• Last Update Submitted: 2013-10-28
• Study First Posted: 2013-11-01
• Last Update Posted: 2013-11-01
• Primary Completion: 2015-06
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Individuals that are 50 years of age and older.

• Patients with retinal capilary abnormalities/vascular diseases such as macular telangiectasia type I and type II, retinal arteriolar macroanurysms, and retinal angiomous proliferation (RAP).
• Patients with diabetic retinopathy and branch retinal vein occlusions
• Other patients who are non-responders to approved treatment methods

Exclusion Criteria

• Patients whose diseases have approved methods of treatment.
• Pregnant women or women of normal child bearing age.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Visudyne	Visudyne	Visudyne half fluence- 1 treatment with the possibility of a second treatment.

Primary Outcome Measures

Name	Time	Method
Improvement and/or stabilization of disease.	1-2 years	The drug, approved for are-related macular degeneration should also prove effective for other permeable conditions, such as retinal capillary/vascular abnormalities that lead to macular edemas such as macular telangiectasia type I and type II, retinal arteriolar macroanurysms, and retinal angiomatous proliferation (RAP), which is a variant of neovascular age-related macular degeneration. These diseases currently have no available approved alternative treatment.

Trial Locations

Locations (1)

Vitreous Retina Macula Consultants of New York; 🇺🇸 New York, New York, United States