Health Condition 1: H353- Degeneration of macula and posterior pole
Conditions
Interventions
Intervention1: Ranibizumab (Xlucane) Intravitreal injection: Xlucane (0.05 mL of 10 mg/mL ranibizumab) in the study eye once every 4 weeks for 52 weeks.
Control Intervention1: Ranibizumab (Lucentis)I
Sponsors
Xbrane Biopharma
Eligibility
Inclusion criteria
Inclusion criteria: 1) Written and signed informed consent form obtained at screening, before any study-related procedures. 2) Willingness and ability to undertake all scheduled visits and assessments as judged by the investigator. 3) Newly diagnosed, active subfoveal Choroidal Neovascularization (CNV) lesion secondary to age-related macular degeneration (AMD) in the study eye. Note: Active CNV indicates the presence of leakage as evidenced by Fluorescein Angiography (FA) and intra- or subretinal fluid as evidenced by Optical Coherence Tomography (OCT) which must be confirmed by the central reading center during Screening: a) The area of CNV must be greater than equal to 50% of the total lesion area in the study eye, and b) Total lesion area Less than equal to 9.0 Disc Areas (DA) in size (including blood, scars and neovascularization) as assessed by FA in the study eye. 4) Best Corrected Visual Acuity (BCVA) of less than equal to 73 and greater than equal to 49 ETDRS letter score in the study eye, using ETDRS chart (20/40 to 20/100 Snellen equivalent) at Screening. 5) Fellow eye should not be expected to need any anti-VEGF treatment for the duration of study participation. 6) Age greater than equal to 50 years at screening. 7) Male and female subjects of childbearing potential must be willing to completely abstain or agree to use an appropriate method of contraception, from the time of signing informed consent and for the duration of study participation through 3 months, following the last dose of study drug.
Exclusion criteria
Exclusion criteria: 1) Any previous intervention including pharmacological treatment, laser and/or surgery for wAMD in either eye; (Exception: Vitamin supplementation for AMD prevention). Any previous vitreoretinal surgery in the study eye for any cause. 2) Any previous IVT treatment including any anti-VEGF medications, steroids and/or any other investigational medication in either eye. 3) The use of long-acting steroids, either systemic or intraocular in any eye, in the 18 months before planned initiation of study treatment. (Note: Iluvien® [fluocinolone acetonide intravitreal], current or planned implantation during the study, is prohibited.) 4) Subfoveal fibrosis, atrophy or scarring extending greater than 50% of total lesion area, in the study eye as assessed by the investigator at screening and confirmed by the central reading center prior to randomization. 5) Choroidal neovascularization in either eye due to non-AMD causes (eg, DME, RVO, ocular histoplasmosis or trauma, etc.) as assessed by FA and confirmed by central reading center. 6) Active or recent (within 28 days prior to randomization) intraocular, extraocular, and periocular inflammation or infection in either eye. 7) History of idiopathic or autoimmune-associated uveitis in either eye. 8) Infectious conjunctivitis, keratitis, scleritis or endophthalmitis in either eye. 9) Unmedicated intraocular pressure (IOP) more then equal to 30 mmHg at Screening in either eye. 10) Topical ocular corticosteroids administered for greater than equal to 30 consecutive days in the study eye within 90 days prior to Screening. 11) Spherical equivalent of the refractive error in the study eye demonstrating greater than 8 diopters of myopia. 12) Corneal transplant or corneal dystrophy in the study eye. History of rhegmatogenous retinal detachment in the study eye. 13) History of macular hole in the study eye. 14) Retinal pigment epithelial tear or rip, involving the macula in the study eye as assessed by FA and confirmed by the central reading center. 15) Current vitreous hemorrhage in the study eye. 16) Subretinal hemorrhage that is greater than equal to 50% of the total lesion area in the study eye, or if the subretinal hemorrhage involves the fovea is 1 or more DA (greater than equal to 2.54 mm2) in size in the study eye, as assessed by FA and confirmed by the central reading center. 17) Other intraocular surgery (including cataract surgery) in the study eye within the 3 months prior to baseline. The yttrium aluminum garnet [YAG] posterior capsulotomy is allowed not later than 4 weeks prior to screening. 18) Any concurrent intraocular condition in the study eye (eg, cataract or diabetic retinopathy) that, in the opinion of the investigator, could require treatment during the study period to prevent or treat loss of visual acuity. 19) Significant media opacities (including cataract) in the study eye interfering with BCVA assessment or fundus imaging (FA/FP/OCT). 20) Aphakia or absence of the posterior capsule in the study eye, unless it occurred as a result of a YAG posterior capsulotomy in association with prior posterior chamber intraocular lens implantation. 21) Presence of advanced glaucoma or optic neuropathy that involve(s) or threaten(s) the central visual field in the study eye (as judged by the investigator). 22) History of glaucoma filtering
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Best Corrected Visual Acuity (BCVA) [ Time Frame: Week 8 ] Change(s) in BCVA letters at Week 8 compared to baseline using the ETDRS protocolTimepoint: Time Frame: Week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in BCVA using the ETDRS protocol Total size of choroidal neovascular leakage area measured by FA Total size of choroidal neovascularization measured by FA Central Foveal Thickness measured by OCT Percentage of subjects with loss of 15 letters using ETDRS Percentage of subjects with a gain of â?¥ 15 letters using ETDRS Number of subjects without intra- or subretinal fluid Number of subjects with retinal pigment epithelium detachments Systemic Ranibizumab concentrationsTimepoint: Day 0, Day 1, Week 2, 4, 8, 16, 20, 24, 36 and 52 | — |
Countries
Bulgaria, Czech Republic, Estonia, Hungary, India, Israel, Latvia, Lithuania, Poland, Romania, Russian Federation, Slovakia, Spain, Ukraine, United States of America
Contacts
Public ContactAbhishek Tyagi
Kendle India Pvt. Ltd.
Outcome results
None listed