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

Manhattan Eye, Ear & Throat Hospital

Status: Unknown

Conditions: Retinal Vascular Disorders

Treatments: Drug: Visudyne

Study type: Interventional

Funder types: Other

Identifiers

NCT01974622

ICG- guided PDT Study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Visudyne

Experimental group

Description:

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

Treatment:

Drug: Visudyne