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

NCT ID: NCT01974622

Last Updated: 2013-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-06-30

Brief Summary

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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

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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.

Conditions

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Retinal Vascular Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Visudyne

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

Group Type EXPERIMENTAL

Visudyne

Intervention Type DRUG

Half fluence verteporfin

Interventions

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Visudyne

Half fluence verteporfin

Intervention Type DRUG

Other Intervention Names

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Verteporfin

Eligibility Criteria

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Inclusion Criteria

* 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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Manhattan Eye, Ear & Throat Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lawrence A. Yannuzzi, M.D.

Role: PRINCIPAL_INVESTIGATOR

Northshore LIJ/MEETH

Locations

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Vitreous Retina Macula Consultants of New York

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Lawrence A. Yannuzzi, M.D.

Role: primary

Irene Barbazetto, M.D.

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 22451952 (View on PubMed)

Other Identifiers

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ICG- guided PDT Study

Identifier Type: -

Identifier Source: org_study_id