Subfoveal Choroidal Neovascularization Associated with Age-Related Macular Degeneration
Conditions
Interventions
Product Name: Squalamine Lactate for Injection
Product Code: MSI-1256F
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Squalamine lactate for Injection
CAS Number: 148717-9
Sponsors
Genaera Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Must be considered reliable, willing and able to give informed consent. 2.Must be =50 years of age, male or female. 3.Must have subfoveal choroidal neovascularization (CNV) lesions associated with age-related macular degeneration (AMD) confirmed on fluorescein angiography in the study eye as predominantly classic, minimally classic or active occult. 4.Active occult lesion must have presumed evidence of disease progression, defined as: deterioration of best-corrected visual acuity (BCVA) by =1 line Snellen (=5 letters on the Early Treatment of Diabetic Retinopathy Study (ETDRS) protocol) within the past 3 months due to progression of CNV (not due to new onset CNV ), and one or more of the following — a.presence of subretinal/intraretinal blood; b.presence of subretinal/intraretinal fluid causing an increase in retinal thickness =250 microns confirmed by optical coherence tomography (OCT); c.growth of the lesion on fluorescein angiogram by =10% within the past 3 months. 5.The following additional criteria must also be met regardless of lesion type — a.lesion diameter =12 disc areas including all lesion components: CNV, blood, blocked fluorescence from lipid, fibrosis, pigment, or hypofluorescence from serous pigment epithelial detachment (PED); b.CNV under the geometric center of the foveal avascular zone; c.area of fibrosis =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1Previous laser photocoagulation therapy for “wet” AMD in the study eye (previous non-foveal photocoagulation and no more than one prior photodynamic therapy [PDT] with verteporfin are allowed). 2.PDT with verteporfin in the study eye within 3 months prior to entering the study. 3.Ocular surgery within the past 3 months for the study eye. 4.Refractive eye surgery within the past 3 months for the study eye 5.Glaucoma with visual field loss in the study eye (glaucoma and treatment in the fellow eye is acceptable). 6.Intraocular pressure = 25 mmHg (off or on medication) in the study eye. 7.History of uveitis in the study eye. 8.Ongoing infection of any sort in either eye at Baseline. 9.Retinal or optic nerve disease that could independently affect visual acuity, including high axial myopia (>-8.00 diopters) or any diabetic retinopathy in the study eye. 10.Anterior segment and vitreous abnormalities that would preclude adequate observation of the fundus for photographs, fluorescein angiography and OCT in the study eye. 11.Use of investigational therapy within 30 days prior to Baseline. 12.Previous treatment with Squalamine Lactate for Injection. 13.Documented uncontrolled diabetes mellitus (best fasting plasma glucose >200 mg/dL in non-insulin dependent diabetes mellitus or >130 mg/dL in insulin-dependent diabetes mellitus). 14.Clinically uncontrolled malignancy (stable disease for 5 years is allowed). 15.Acute atrial fibrillation; recent myocardial infarction (10mg prednisone or equivalent /day) within the past 6 months. 21.Use of topical steroids in the study eye within the past 1 month. 22.Use of any antiangiogenic compound locally or systemically (eg, thalidomide, bevacizumab (Avastin®) - see Study Reference Manual for complete list).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and efficacy of two doses (40 mg and 20mg) of Squalamine Lactate for Injection administered as intravenous infusions weekly for 4 weeks followed by maintenance doses every 4 weeks through week 104, compared with the safety and efficacy in the control group;Secondary Objective: ;Primary end point(s): Loss in BCVA of = 15 letters (ETDRS) at 52 weeks in the study eye compared to baseline. Secondary endpoints are as follows: 1. Loss in BCVA of =15 letters (ETDRS) at 104 weeks in the study eye compared to baseline. 2. Gain in BCVA of =15 letters (ETDRS) at 52 and 104 weeks in the study eye compared to baseline. 3. Loss in BCVA of =15 letters (ETDRS) at 52 and 104 weeks in the fellow eye compared to baseline in the subgroup of subjects whose fellow eye is affected with “wet” AMD (ie, subfoveal CNV lesions due to AMD confirmed on fluorescein angiography as predominantly classic, minimally classic or active occult). 4. Gain in BCVA of =15 letters (ETDRS) at 52 and 104 weeks in the fellow eye compared to baseline in the subgroup of subjects whose fellow eye is affected with wet AMD. 5. Loss in binocular visual acuity of =15 letters at 52 and 104 weeks compared to baseline, using a modified ETDRS protocol. 6. Gain in binocular visual acuity of =15 letters at 52 and 104 weeks compared to baseline, using a modified ETDRS protocol. 7. Change in visual functioning and health-related quality of life at 52 and 104 weeks compared to baseline, as measured by the National Eye Institute Visual Functioning Questionnaire-25 (VFQ-25). 8. Change in retinal thickness (Bruch’s membrane to inner limiting membrane [ILM]) in the study eye at 52 and 104 weeks compared to baseline, as measured by OCT, in a subset of subjects. 9. Change in area of CNV in the study eye at 52 and 104 weeks compared to baseline, as measured by fluorescein angiography. | — |
Countries
Spain
Outcome results
None listed