Study Detail: Ohr Squalamine Eye Drops for Wet AMD
Trial Description Summary
Participants are newly diagnosed, never treated wet macular degeneration in one eye who will intially be treated with one dose of Lucentis. They will then be randomly assigned to either squalamine eye drops twice a day or placebo eye drops twice a day. The need for subsequent injections of Lucentis will be evaluated monthly (weeks 4-32) and it retreatment criteria are met, Lucentis will be administered.
Basic Trial Information
Disease Status: newly diagnosed, never treated wet AMD
Age: 50 years or older
Sponsor: Ohr Pharmaceutical
Protocol Number: Ohr-002
Status: anticipated enrollment Fall 2012
Study Duration: 9 months
Greater than 50 years old. No upper limit.
Diagnosis of CNV secondary to AMD
Total lesion area less than or equal to 12 disc areas
CNV affecting at least 50% of the total lesion area
If hemorrhage must be 50% or less of the lesion- and no blood under the fovea
No fibrosis or atrophy, retinal epithelial tear in the center of the fovea in the study eye or any condition preventing VA improvement
No pigment epithelial detachments without subretinal fluid or cystoid edema
Central retinal thickness greater than or equal to 300 microns on Cirrus OCT
Presence of sub-retinal fluid or cystoid edema on OCT.
VA 20/40 to 20/320 (25 to 70 letters ETDRS)
If cataract extraction in the study eye, must be more than 3 months prior to enrollment as long as the PC-IOL is in place.
CNV secondary to any condition other than AMD in the study eye
Prior treatment in the study eye- CNV tx. allowed in fellow eye
Confounding ocular conditions such as diabetic retinopathy
VA worse that 20/200 (less than 34 letters) in the fellow eye
Prior ocular surgery in study eye (vitrectomy, scleral buckle
Glaucoma with the patient receiving treatment and having a VF defect or having had a filter/shunt
Cataract extraction less than 3 months prior to enrollment
Wearing of contact lenses
General Medical Exclusion
Myocardial infarction, cerebrovascular accident or transient ischemic attacks (TIA) within the past six months.
Currently on chemotherapy
Currently on systemic steroids
Investigational product use of any kind in the previous 30 days
Other inclusion/exclusion criteria per protocol to be screened by the Clinical Coordinator
Phase II study of the efficacy and safety of squalamine lactate in ophthalmic formulation 0.2% BID insubjects with neovascular AMD
Trial Contact Information
Study Coordinator: Vivian
Contact info: 216/831-5704 ext. 253