Health Condition 1: H353- Degeneration of macula and posterior pole
Conditions
Interventions
Intervention1: GBL1204: Inj. GBL1204, at a dose of 1.25 mg in 0.05 mL will be administered Intravitreally once every 4 weeks in the study eye until week 12.
The total study duration for each subject
Sponsors
Gennova Biopharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Adult male or female subjects of age equal to or more than 50 years including non-diabetics or subjects with controlled diabetes with prescribed medication who are capable of understanding and giving written informed consent 2.Subjects with a diagnosis of wet AMD confirmed by fluorescein angiography showing the presence of active subfoveal choroidal neovascularization CNV This includes, a.newly diagnosed active CNV lesion or b.previously untreated active CNV lesion or c.subjects with prior treatment of the active CNV lesion at least three months before the enrolment Active CNV is defined as any leakage detected on FA 3.Total lesion area less than or equal to 12.0 Disc Areas DA in size in the study eye 4.BCVA between 20/320 to 20/40 Snellen equivalent both value inclusive in the study eye before pupil dilation assessed using the ETDRS visual acuity charts 5.Women of non-childbearing potential i e postmenopausal for at least 12 months prior to trial entry, or surgically sterile OR if of childbearing potential a pregnancy test with a negative result must be obtained prior to the first treatment Women of childbearing potential must practice effective contraception during the trial and for at least 60 days following the last dose of the study injection 6.No known contraindication to intravitreal injection of GBL1204 or ranibizumab 7.Willing and able to undertake all scheduled visits and assessments
Exclusion criteria
Exclusion criteria: 1.Subjects with the presence of other significant ocular disorders in the study eye affecting visual acuity, such as:Sub-retinal hemorrhage covering more than 50% of the total lesion area involving the center of the fovea as assessed by FA, scar, fibrosis, or atrophy, involving the center of the fovea, making up more than 50 percent of the total lesion as assessed by FA, retinal pigment epithelial tear involving the macula, presence of a macular hole at any stage, uncontrolled glaucoma (intraocular pressure exceeding 25 mmHg despite treatment) or any other retinal or macular abnormality (other than AMD) that could affect central vision or the efficacy assessments in the study eye. 2.The presence of CNV in the study eye due to other causes, such as ocular histoplasmosis, trauma, angioid streaks, choroidal rupture, pathologic myopia (spherical equivalent of -8.0 diopters or more, or axial length of 25 mm or more), or multifocal choroiditis. 3.Subjects who, in the opinion of the principal investigator (PI), may require medical or surgical intervention within 4 to 5 months of study period, or for whom the decision to prevent surgery or treatment would lead to a loss of best corrected visual acuity during the study period. 4.Subjects, who are unable to be photographed to document CNV, due to known allergy to fluorescein dye, lack of venous access, or cataracts obscuring the CNV. 5.Subject with dense corneal and lens opacities, obstructing the view of central retina. 6.Known hypersensitivity to the components of the study medication (bevacizumab or ranibizumab). 7.Previous treatment with verteporfin PDT, Macugen, ranibizumab, intravitreal Avastin®, thermal laser, external beam radiation, intravitreal steroids, or other AMD therapy in the study eye (except for extrafoveal laser photocoagulation) as well as the contralateral non-study eye within past 3 months before enrolment in the study. 8.Laser photocoagulation in the study eye within 1 month prior to enrolment in the study. 9.Concurrent or any prior use of systemic anti-vascular endothelial growth factor (VEGF) agents. 10.Concurrent treatment with an investigational drug or any medical device in the either eye or less than 30 days or 5 half-lives (whichever is longer) since ending treatment on another investigational drug or device study(ies) prior to enrolment. 11.History or clinical evidence of diabetic retinopathy, diabetic macular edema (DME), or any other vascular disease affecting the retina, other than AMD, in either eye. 12.History of vitrectomy, any vitreous hemorrhage, rhegmatogenous retinal detachment, or macular hole in the study eye. 13.History of submacular surgery or other surgical intervention for AMD in the study eye. 14.Active intraocular inflammation including scleritis or active or suspected ocular or periocular infection in either eye (including infectious conjunctivitis, keratitis, scleritis, uveitis, or endophthalmitis), within 2 weeks prior to randomization. 15.History of any intraocular or periocular surgery (including cataract surgery) in the study eye within 2 months prior to enrolment in the study. 16.Having corneal transplant in the study eye. 17.Presence or history of scleromalacia in either eye. 18.For subjects who have undergone prior refractive or cataract surgery in the study eye, the preoperative refractive error in the study eye ca
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in best corrected visual acuity (BCVA) in subjects in both groups.Timepoint: Baseline to Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy Proportion of subjects who gained 15 letters or more on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. Proportion of subjects who lost fewer than 15 letters on the ETDRS chart. Mean change in central macular thickness as assessed by optical coherence tomography (OCT) in the study eye. Safety Incidence of ocular & non-ocular treatment emergent adverse events (TEAEs) & serious adverse events (SAEs). Exploratory Change in National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) total score. Proportion of patients with anti-drug antibodies (ADAs) againts GBL1204 & ranibizumab. Timepoint: Efficacy Baseline to Week 16 Safety Baseline to Week 16 Exploratory Baseline to Week 16 | — |
Countries
India
Contacts
Public ContactDr Amit Saraf
Gennova Biopharmaceuticals Limited
Outcome results
None listed