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Study of Talaporfin Sodium Photodynamic Therapy to Treat Advanced Age Related Macular Disease

Primary Purpose

Macular Degeneration, Choroidal Neovascularization

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Talaporfin Sodium (LS11) Photodynamic Therapy (PDT)
Sponsored by
Light Sciences LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Degeneration focused on measuring Macular disease, Wet AMD, AMD, Age-Related Macular Disease, PDT, Photodynamic Therapy

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 50 or older Subject is able to sign informed consent Ability to complete 6 month trial Present with advanced AMD and persistently leaking CNV Adequate hematologic, renal and liver function Negative pregnancy test Subject is able to safely undertake all protocol directed instructions Visual acuity of 20/200 (logMAR 1.0)(6/60) or worse Exclusion Criteria: Concomitant eye disease in eye to be treated Prior ocular radionuclide treatments Known allergic or hypersensitivity reactions to light and/or fluorescein and iodine or shellfish History of investigational drug or therapy including biologics within 30 days prior to the study drug dosing Women who are pregnant or lactating, or women of childbearing years not taking adequate contraception precautions History of porphyria, systemic lupus erythematosus, or xeroderma pigmentosum History of clinically significant cardiovascular abnormalities, including myocardial infarction in the past 6 months, uncontrolled arrhythmias, uncontrolled congestive heart failure Concomitant use of other drugs known to produce skin photosensitivity, e.g. tetracycline, sulfonamides, phenothiazines, sulfonylureas, thiazide diuretics and griseofulvin, St. John's Wort Subjects with high or pathological myopia with an axial length > 26mm or a refractive error of >/= -8.00D Subjects with glaucoma and vision loss in either eye Subject with a history of other choroidal leakage, e.g. histoplasmosis Subjects with significant media opacity Subjects diagnosed with diabetic retinopathy Subjects who have had eye surgery within the past 3 months Subjects who have received PDT treatment for AMD in the treatment eye Any disease or condition that the sponsor or the investigator believes will impact the subject's ability to adhere to the study schedule Subjects participating in any concurrent trial

Sites / Locations

  • Texas Retina

Outcomes

Primary Outcome Measures

Cessation of leakage from choroidal neovascularization (CNV) of subjects with late stage AMD

Secondary Outcome Measures

Changes in visual performance

Full Information

First Posted
January 21, 2005
Last Updated
March 11, 2010
Sponsor
Light Sciences LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00102115
Brief Title
Study of Talaporfin Sodium Photodynamic Therapy to Treat Advanced Age Related Macular Disease
Official Title
Phase 1 Dose Ranging Study to Evaluate Safety and Tolerability of Talaporfin Sodium (LS11) Photodynamic Therapy in Subjects With Advanced Age-Related Macular Disease
Study Type
Interventional

2. Study Status

Record Verification Date
December 2005
Overall Recruitment Status
Terminated
Study Start Date
December 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Light Sciences LLC

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to determine the safety and tolerability of Talaporfin Sodium (LS11) Photodynamic Therapy in patients with late stage Age-Related Macular Disease (AMD).
Detailed Description
This Phase 1 study is a safety and tolerability investigation of LS11 photodynamic therapy in subjects with persistent leaking neovascular membranes in patients with AMD who have a visual acuity of 20/200 or less. This is a sequential group dose escalation trial with the cohorts defined by increasing the light dose. Within each light-dose cohort, three (3) subjects will be treated at a drug dose of 0.2 mg/kg or 0.5 mg/kg.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration, Choroidal Neovascularization
Keywords
Macular disease, Wet AMD, AMD, Age-Related Macular Disease, PDT, Photodynamic Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Talaporfin Sodium (LS11) Photodynamic Therapy (PDT)
Primary Outcome Measure Information:
Title
Cessation of leakage from choroidal neovascularization (CNV) of subjects with late stage AMD
Secondary Outcome Measure Information:
Title
Changes in visual performance

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 50 or older Subject is able to sign informed consent Ability to complete 6 month trial Present with advanced AMD and persistently leaking CNV Adequate hematologic, renal and liver function Negative pregnancy test Subject is able to safely undertake all protocol directed instructions Visual acuity of 20/200 (logMAR 1.0)(6/60) or worse Exclusion Criteria: Concomitant eye disease in eye to be treated Prior ocular radionuclide treatments Known allergic or hypersensitivity reactions to light and/or fluorescein and iodine or shellfish History of investigational drug or therapy including biologics within 30 days prior to the study drug dosing Women who are pregnant or lactating, or women of childbearing years not taking adequate contraception precautions History of porphyria, systemic lupus erythematosus, or xeroderma pigmentosum History of clinically significant cardiovascular abnormalities, including myocardial infarction in the past 6 months, uncontrolled arrhythmias, uncontrolled congestive heart failure Concomitant use of other drugs known to produce skin photosensitivity, e.g. tetracycline, sulfonamides, phenothiazines, sulfonylureas, thiazide diuretics and griseofulvin, St. John's Wort Subjects with high or pathological myopia with an axial length > 26mm or a refractive error of >/= -8.00D Subjects with glaucoma and vision loss in either eye Subject with a history of other choroidal leakage, e.g. histoplasmosis Subjects with significant media opacity Subjects diagnosed with diabetic retinopathy Subjects who have had eye surgery within the past 3 months Subjects who have received PDT treatment for AMD in the treatment eye Any disease or condition that the sponsor or the investigator believes will impact the subject's ability to adhere to the study schedule Subjects participating in any concurrent trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Krasner, PhD
Organizational Affiliation
Light Sciences LLC
Official's Role
Study Director
Facility Information:
Facility Name
Texas Retina
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.lsoncology.com/
Description
Study sponsor

Learn more about this trial

Study of Talaporfin Sodium Photodynamic Therapy to Treat Advanced Age Related Macular Disease

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