Trial Search Results

Efficacy and Safety Study of Squalamine Ophthalmic Solution in Subjects With Neovascular AMD

A Phase 3 Study of the Efficacy and Safety of Squalamine Lactate Ophthalmic Solution 0.2% Twice Daily in Subjects with Neovascular Age-Related Macular Degeneration. Patients will receive injections of ranibizumab. In addition, patients will receive either Squalamine lactate 0.2% eye drops or Placebo eye drops. The study duration is approximately 9 months to primary endpoint

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Ohr Pharmaceutical Inc.

Stanford Investigator(s):

Intervention(s):

  • Drug: Squalamine lactate ophthalmic solution, 0.2%
  • Drug: Placebo Ophthalmic solution
  • Drug: ranibizumab

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - Age ≥ 50 years

   - A diagnosis of choroid neovascularization (CNV) secondary to AMD with CNV comprising
   at least 50% of the total lesion area on fluorescein angiography (FA)

   - Central subfield thickness (spectral domain (SD)-OCT central 1 mm) of ≥ 300 μm

   - Best-corrected visual acuity (BCVA) 20/40 to 20/320 (73- to 24-letter score on the
   Early Treatment of Diabetic Retinopathy Study [ETDRS] chart)

Exclusion Criteria:

   - Neovascularization secondary to any other condition than AMD in the study eye; Blood
   occupying greater than 50% of the AMD lesion, or blood > 1.0 sq. mm underlying the
   fovea

   - Pigment epithelial detachment (PED) without associated subretinal fluid and/or cystic
   retinal changes

   - Clinical evidence of diabetic retinopathy or diabetic macular edema in the study eye

   - Confounding ocular conditions in the study eye which will affect interpretation of
   OCT, VA or assessment of macular appearance (e.g., cataract, epiretinal membrane,
   retinal vascular occlusive disease)

   - Fibrosis or atrophy, retinal epithelial tear in the center of the fovea in the study
   eye or any condition preventing VA improvement

   - Uncontrolled glaucoma in the study eye, or currently receiving topical glaucoma
   medication in the study eye

Ages Eligible for Study

50 Years - 110 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Recruiting