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

Retinal Vascular Disorders Clinical Trial

— ICGguidedPDT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01974622
• Other study ID #: ICG- guided PDT Study
• Status: Recruiting
• Phase: N/A
• First received: October 28, 2013
• Last updated: October 28, 2013
• Start date: April 2013
• Est. completion date: June 2015

Study information

• Verified date: October 2013
• Source: Manhattan Eye, Ear & Throat Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Retinal Vascular Disorders
• Vascular Diseases

Intervention

Drug:
• Visudyne
Half fluence verteporfin

Locations

Country	Name	City	State
United States	Vitreous Retina Macula Consultants of New York	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Manhattan Eye, Ear & Throat Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement and/or stabilization of disease.	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.	1-2 years	No