OHR-1601: 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
Principal Investigator:Mihai Mititelu
Study Coordinator:Kris Dietzman
Study Objective:To evaluate the efficacy and safety of Squalamine lactate ophthalmic solution, 0.2% BID in combination with intravitreal (IVT) injections of ranibizumab in treatment-naïve subjects with neovascular age-related macular degeneration (AMD).
Study Eligibility Criteria:
Study Inclusion Criteria:
Age ≥ 50 years
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 fluorescein 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 CRC.
Central subfield thickness (spectral domain (SD)-OCT central 1 mm) of ≥ 300 μm
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)
In the event that both eyes meet study inclusion/exclusion criteria, the study eye will be selected based on the discretion of the Investigator (only one eye will be enrolled as the study eye).
Female subjects must be at least 1 year postmenopausal, surgically sterilized, or if of childbearing potential have a negative urine pregnancy test at Screening/Baseline. Women of childbearing potential must agree to use an acceptable method of contraception throughout the study
Be willing and able to provide written informed consent prior to participation in any study-related procedures
Able to self-administer study medication (drops) or have the study medication administered by a caregiver throughout the study
Be willing and able to return for all scheduled treatment and follow-up examinations for the duration of the study
Study Exclusion Criteria:
Neovascularization secondary to any condition other than wet AMD in the study eye
Blood occupying greater than 50% of the AMD lesion or blood > 1.0 mm2 underlying the fovea in the study eye
Pigment epithelial detachment without associated subretinal fluid and/or cystic retinal changes in the study eye
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
Any prior treatment in the study eye for neovascular AMD, including treatment with IVT bevacizumab, ranibizumab, aflibercept, photodynamic therapy, submacular surgery, intraocular steroid, or any antiangiogenic drug for AMD
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 occlusive disease)
Clinical evidence of diabetic retinopathy or diabetic macular edema in the study eye
Uncontrolled glaucoma in the study eye, or currently receiving topical glaucoma medication in the study eye
Current ocular or periocular infection in the study eye
BCVA worse than 20/200 (less than 34 letters) in the fellow (non-study) eye
Prior ocular surgery in the study eye (e.g., vitrectomy, scleral buckle, or glaucoma filter/shunt; however, yttrium-aluminum-garnet [YAG] laser capsulotomy at least 3 months prior to enrollment is allowed). Cataract surgery more than 3 months prior to enrollment is allowed as long as a posterior chamber intraocular lens is in place.
Contact lens wear
Severe dry eye requiring artificial tear use more than 4 times a day
Unable to administer eye drops reliably, or unable to guarantee that installation of study medication will occur regularly for the duration of the clinical study
Concomitant therapy with any drug that may affect VA, or medications that may be toxic to the lens/retina or optic nerve
Prior laser treatment in the study eye
Currently on systemic corticosteroids or systemic corticosteroid use within 4 weeks prior to screening. Nasal corticosteroids and inhalers are allowed.
Myocardial infarction or cerebrovascular accident or transient ischemic attack within the past 6 months
Uncontrolled hypertension (diastolic blood pressure > 105 mm Hg) in spite of antihypertensive medications
For more information please call Kris Dietzman at 608-263-9035