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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase 1 Dose Ranging Study to Evaluate Safety and Tolerability of Talaporfin Sodium (LS11) Photodynamic Therapy in Subjects With Advanced Age-Related Macular Disease

Conditions
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Macular Degeneration, Choroidal Neovascularization

Intervention / Treatment
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* Drug: Talaporfin Sodium (LS11) Photodynamic Therapy (PDT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Talaporfin Sodium (LS11) Photodynamic Therapy (PDT)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cessation of leakage from choroidal neovascularization (CNV) of subjects with late stage AMD |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in visual performance |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Macular disease, Wet AMD, AMD, Age-Related Macular Disease, PDT, Photodynamic Therapy