- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01974622
ICG-Guided Photodynamic Therapy for Treatment of Retinal Capillary Abnormalities: A Pilot Study (ICGguidedPDT)
October 28, 2013 updated by: Manhattan Eye, Ear & Throat Hospital
Indocyanine Green Angiography-Guided Photodynamic Therapy for Treatment of Retinal Capillary Abnormalities.
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.
Study Overview
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 Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10022
- Recruiting
- Vitreous Retina Macula Consultants of New York
-
Contact:
- Lawrence A. Yannuzzi, M.D.
- Phone Number: 212-605-3777
- Email: layannuzzi@gmail.com
-
Contact:
- Irene Barbazetto, M.D.
- Phone Number: (212) 861-9797
- Email: ibarbazetto@gmail.com
-
Principal Investigator:
- Lawrence A. Yannuzzi, M.D.
-
Sub-Investigator:
- Irene Barbazetto, M.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Visudyne
Visudyne half fluence- 1 treatment with the possibility of a second treatment.
|
Half fluence verteporfin
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement and/or stabilization of disease.
Time Frame: 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.
|
1-2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Lawrence A. Yannuzzi, M.D., Northshore LIJ/MEETH
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2013
Primary Completion (ANTICIPATED)
June 1, 2015
Study Completion (ANTICIPATED)
June 1, 2015
Study Registration Dates
First Submitted
October 28, 2013
First Submitted That Met QC Criteria
October 28, 2013
First Posted (ESTIMATE)
November 1, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
November 1, 2013
Last Update Submitted That Met QC Criteria
October 28, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ICG- guided PDT Study
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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