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

Information source: Manhattan Eye, Ear & Throat Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Retinal Vascular Disorders

Intervention: Visudyne (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Manhattan Eye, Ear & Throat Hospital

Official(s) and/or principal investigator(s):
Lawrence A. Yannuzzi, M.D., Principal Investigator, Affiliation: Northshore LIJ/MEETH

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.

Clinical Details

Official title: Indocyanine Green Angiography-Guided Photodynamic Therapy for Treatment of Retinal Capillary Abnormalities.

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Improvement and/or stabilization of disease.

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.

Eligibility

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Vitreous Retina Macula Consultants of New York, New York, New York 10022, United States; Recruiting
Lawrence A. Yannuzzi, M.D., Phone: 212-605-3777, Email: layannuzzi@gmail.com
Irene Barbazetto, M.D., Phone: (212) 861-9797, Email: ibarbazetto@gmail.com
Lawrence A. Yannuzzi, M.D., Principal Investigator
Irene Barbazetto, M.D., Sub-Investigator
Additional Information

Related publications:

Yannuzzi LA, Slakter JS, Gross NE, Spaide RF, Costa DL, Huang SJ, Klancnik JM Jr, Aizman A. Indocyanine green angiography-guided photodynamic therapy for treatment of chronic central serous chorioretinopathy: a pilot study. 2003. Retina. 2012 Feb;32 Suppl 1:288-98.

Starting date: April 2013
Last updated: October 28, 2013

Page last updated: August 23, 2015

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