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Squalamine Lactate in Wet AMD
NCT00139282Phase 3
Key facts
- Status
- Terminated
- Start
- Jun 2005
- Countries
- 1
- Sponsor
- Genaera Corporation
- Modality
- Multivalent & Scaffold-Based Small Molecules, Nucleic Acid-Directed Small Molecules
- Drugs
- squalamine
- Conditions
- exudative macular degeneration
01
Overview
Phase 3, randomised, double-blind trial of squalamine in exudative macular degeneration (3 arms), sponsored by Genaera Corporation. Primary endpoint: Loss in Best Corrected Visual Acuity of >= 15 letters at 52 weeks. Started Jun 2005; status: terminated.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Squalamine Dose 1
Squalamine lactate IV infusion (Dose 1)
Squalamine Dose 2
Squalamine lactate IV infusion (Dose 2)
Control
Placebo IV infusion
03
Who it enrols
Patients 50 years or older with a diagnosis of wet AMD who have not received treatment in the affected eye in the past 3 months.
04
Endpoints
Primary
Loss in Best Corrected Visual Acuity of >= 15 letters
Secondary
Change in Retinal Thickness
Change in Area of Choroidal Neovascularization
Gain or Loss in BCVA of >= 15 letters in Fellow Eye
Loss in Binocular Visual Acuity of >= 15 letters
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