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

Primary Purpose

Retinal Vascular Disorders

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Visudyne
Sponsored by
Manhattan Eye, Ear & Throat Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinal Vascular Disorders

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Vitreous Retina Macula Consultants of New YorkRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Visudyne

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 28, 2013
Last Updated
October 28, 2013
Sponsor
Manhattan Eye, Ear & Throat Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01974622
Brief Title
ICG-Guided Photodynamic Therapy for Treatment of Retinal Capillary Abnormalities: A Pilot Study
Acronym
ICGguidedPDT
Official Title
Indocyanine Green Angiography-Guided Photodynamic Therapy for Treatment of Retinal Capillary Abnormalities.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
June 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Manhattan Eye, Ear & Throat Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Vascular Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Visudyne
Arm Type
Experimental
Arm Description
Visudyne half fluence- 1 treatment with the possibility of a second treatment.
Intervention Type
Drug
Intervention Name(s)
Visudyne
Other Intervention Name(s)
Verteporfin
Intervention Description
Half fluence verteporfin
Primary Outcome Measure Information:
Title
Improvement and/or stabilization of disease.
Description
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.
Time Frame
1-2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence A. Yannuzzi, M.D.
Organizational Affiliation
Northshore LIJ/MEETH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vitreous Retina Macula Consultants of New York
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lawrence A. Yannuzzi, M.D.
Phone
212-605-3777
Email
layannuzzi@gmail.com
First Name & Middle Initial & Last Name & Degree
Irene Barbazetto, M.D.
Phone
(212) 861-9797
Email
ibarbazetto@gmail.com
First Name & Middle Initial & Last Name & Degree
Lawrence A. Yannuzzi, M.D.
First Name & Middle Initial & Last Name & Degree
Irene Barbazetto, M.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
22451952
Citation
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.
Results Reference
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ICG-Guided Photodynamic Therapy for Treatment of Retinal Capillary Abnormalities: A Pilot Study

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