ICG-Guided Photodynamic Therapy for Treatment of Retinal Capillary Abnormalities: A Pilot Study
ICGguidedPDT
Indocyanine Green Angiography-Guided Photodynamic Therapy for Treatment of Retinal Capillary Abnormalities.
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 28, 2013
CompletedFirst Posted
Study publicly available on registry
November 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedNovember 1, 2013
October 1, 2013
2.2 years
October 28, 2013
October 28, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Visudyne
EXPERIMENTALVisudyne half fluence- 1 treatment with the possibility of a second treatment.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients whose diseases have approved methods of treatment.
- Pregnant women or women of normal child bearing age.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vitreous Retina Macula Consultants of New York
New York, New York, 10022, United States
Related 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. doi: 10.1097/iae.0b013e31823f99a9.
PMID: 22451952BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lawrence A. Yannuzzi, M.D.
Northshore LIJ/MEETH
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2013
First Posted
November 1, 2013
Study Start
April 1, 2013
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
November 1, 2013
Record last verified: 2013-10