Clinical trial NCT00102115: 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
Overall status: TERMINATED
Phase: PHASE1
Conditions: Macular Degeneration
Choroidal Neovascularization
Keywords: Macular disease
Wet AMD
AMD
Age-Related Macular Disease
PDT
Photodynamic Therapy
Lead sponsor: Light Sciences LLC
Sponsor class: INDUSTRY
First posted: 2005-01-24
Enrollment: 27
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Cessation of leakage from choroidal neovascularization (CNV) of subjects with late stage AMD
Secondary outcomes:
measure: Changes in visual performance
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Texas Retina
state: Texas
Study officials:
affiliation: Light Sciences LLC
name: Gary Krasner, PhD
role: STUDY_DIRECTOR
References: