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Ohr MAKO - Wet AMD
A Phase III, Study of the Efficacy and Safety of Squalamine Lactate Ophthalmic Solution, 0.2% Twice Daily in Subjects with Neovascular Age-Related Macular Degeneration

Study Site: We are enrolling patients in this study at the WEST location

Inclusion Criteria:
  1. Age > 50 years
  2. Meet the following criteria in the study eye:
  • A diagnosis of choroid neovascularization (CNV) secondary to AMD with CNV comprising at least 50% of the total lesion area on flurorescein angiography (FA).  The CNV lesion may contain classic and/or occult CNV; however, the occult CNV component must measure less than 10.0 mm2 as assessed on FA by the investigator and confirmed by the Clinical Research Coordinator (CRC).
  • Central subfield thickness (spectral domain [SD]-OCT central 1 mm) of > 300 um
  • No previous treatment in the study eye for neovascular AMD
  • Presence of subretinal or intraretinal fluid (cystic spaces) on OCT
  • 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:
  1. Neovascularization secondary to any condition other than wet AMD in the study eye
  2. Blood occupying greater that 50% of the AMD lesion or blood > 1.0 mm2 underlying the fovea in the study eye
  3. Pigment epithelial detachment without associated subretinal fluid and/or cystic retinal changes in the study eye
  4. Fibrosis, atrophy or retinal epithelial tear in the center of the fovea of the study eye, or any other condition preventing visual acuity (VA) improvement
  5. Any prior treatment in the study eye for neovascular AMD, including treatment with IVT bevacizumab, ranbizumab, aflibercept, photodynamic therapy (PDT), submacular surgery, intraocular steroid or any antiangiogenic drug for AMD
  6. Confounding ocular conditions in the study eye that may affect interpretation of OCT, VA or assessment of macular appearance (e.g. cataract, epiretinal membrane, retinal vascular disease)
  7. Clinical evidence of diabetic retinopathy or diabetic macular edema in the study eye
  8. Uncontrolled glaucome in the study eye or currently receiving topical glaucoma medication in the study eye
  9. Current ocular or periocular infection in the study eye
  10. BCVA worse than 20/200 (less than 34 letters) in the fellow (non-study) eye
Principal Investigator:

Dr. Kim Krummenacher

Sub Investigators:

Dr. Kevin J. Blinder
Dr. Matthew A. Thomas
Dr. Yicheng Chen
Dr. Abdallah Jeroudi

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