Clinical trial NCT00333476: A Study of MSI-1256F (Squalamine Lactate) To Treat "Wet" Age-Related Macular Degeneration
Official title: A Phase 2, Randomized, Open Label, Safety, and Pharmacodynamic Study of Squalamine Lactate for Injection for the Treatment of Minimally Classic or Active Occult Choroidal Neovascularization Associated With Age-Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Macular Degeneration
Lead sponsor: Genaera Corporation
Sponsor class: INDUSTRY
First posted: 2006-06-05
Enrollment: 140
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Age-Related Macular Degeneration (AMD) is a degenerative eye disease of the retina that causes a progressive loss of central vision. AMD is the leading cause of legal blindness among adults age 50 or older in the Western world. AMD presents in two different types - "dry" and the more severe "wet" form. Wet AMD is caused by the growth of abnormal blood vessels in the macula. Squalamine lactate is an investigational drug that may prevent the growth of these abnormal blood vessels. This study will test the safety and efficacy of Squalamine in the treatment of AMD.


Eligibility criteria: Inclusion Criteria:

* Adult subjects ≥ 50 years of age.
* minimally classic or active occult choroidal neovascularization associated with age-related macular degeneration in one or both eyes.
* baseline best corrected visual acuity score between 35 to 65 letters according to the Early Treatment of Diabetic Retinopathy Study protocol.
* central retinal thickness by optical coherence tomography of \> 250 microns.
* lesions \> 9 disc areas.
* \> 25% fibrosis in the lesion.

Exclusion Criteria:

* Previous history of triamcinolone, bevacizumab, ranibizumab, or pegaptanib sodium injection therapy in the study eye.
* retinal or optic nerve disease.
* uncontrolled diabetes.
* ongoing malignancy.

Primary outcomes:
measure: To evaluate the safety profile of squalamine lactate at doses ranging from 40 mg to 160 mg of squalamine lactate
Secondary outcomes:
measure: To evaluate short-term effects on best corrected visual acuity and changes in subretinal CNV as measured by optical coherence tomography
measure: To evaluate short-term effects on best corrected visual acuity and changes in subretinal CNV as measured by fluorescein angiography
Other outcomes:
Locations:
city: Boynton Beach
country: United States
facility: Florida Eye Microsurgical Institute
state: Florida
city: Fort Meyers
country: United States
facility: Retina Health Center
state: Florida
city: Miami
country: United States
facility: Bascom Palmer Eye Institute
state: Florida
city: Indianapolis
country: United States
facility: Midwest Eye Institute
state: Indiana
city: Towson
country: United States
facility: Retina Specialists
state: Maryland
city: Kansas City
country: United States
facility: Eye Foundation of Kansas City
state: Missouri
city: Long Island
country: United States
facility: Ophthalmic Consultants of Long Island
state: New York
city: Rochester
country: United States
facility: Retina Associates of Western New York
state: New York
city: Houston
country: United States
facility: Charles Garcia, MD, P.A.
state: Texas
Study officials:
affiliation: Florida Eye Microsurgical Institute, Inc.
name: Randy Katz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Retina Health Center
name: Alexander Eaton, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Midwest Eye Institute
name: Thomas Ciulla, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Retina Specialists
name: Raymond Sjaarda, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Eye Foundation of Kansas City
name: Nelson Sabates, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Charles Garcia, MD, P.A.
name: Charles Garcia, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ophthalmic Consultants of Long Island
name: Glenn Stoller, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bascom Palmer Eye Institute
name: Phillip Rosenfeld, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Retina Associates of Western New York
name: Steven Rose, MD
role: PRINCIPAL_INVESTIGATOR
References: