Health Condition 1: H353- Degeneration of macula and posterior pole
Conditions
Interventions
Intervention1: ENZ105- Ranibizumab Injection 10mg/ml: Dose: 0.5 mg (0.05 mL) Duration: once every 4 weeks for 12 weeks (total 03 doses) Route of administration: intravitreal injection
Control Interven
Sponsors
Enzene Biosciences Ltd.
Alkem Laboratories Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Willing to provide voluntary written informed consent. 2. Male or female participant with age more than equa; 50 years at the time of screening. 3. Subjects with treatment-naive CNV (choroidal neovascularization) secondary to AMD, involving the foveal center. 4. Have a best corrected visual acuity of 20/40 to 20/320 using Early Treatment Diabetic Retinopathy Study chart- ETDRS (Snellen equivalent) in the study eye. 5. Willing and able to comply with protocol.
Exclusion criteria
Exclusion criteria: 1.Known hypersensitivity to Ranibizumab or any of the components of study medication. 2. Prior treatment with any intravitreal drug, verteporfin or photodynamic therapy in the study eye in the past (except for extrafoveal laser photocoagulation in the study eye) and/or non-study eye within past 3 months before enrollment in the study. 3. Laser photocoagulation in the study eye within 1 month before screening the subject. 4. Subject with vision only in one eye. 5. Subfoveal fibrosis or Subfoveal atrophy in the study eye. 6. Prior treatment with any anti-VEGF therapy in last 6 months 7. CNV in either of the two eyes due to causes other than AMD such as histoplasmosis or pathological myopia etc. 8. Retinal pigment epithelial tear involving the macula in the study eye. 9. Any concurrent intraocular condition in the study eye that could either require medical or surgical intervention during the study period or that could contribute to a loss of best corrected visual acuity score over the study period (e.g. diabetic retinopathy, cataract, uncontrolled glaucoma or Intraocular pressure of more than equal 30 mmHg, uveitis, previous corneal transplant, recent cataract surgery etc.). The decision regarding exclusion is to be based on the opinion of the investigator. 10. Presence of any uncontrolled systemic disease (e.g. cardiovascular disease, hypertension, diabetes mellitus etc.) 11. History of myocardial infraction (MI), stroke or Transient ischaemic attack (TIA) within 01 year of study participation 12. Known history of peripheral vasculopathy, peripheral arterial disease within 01 year of study participation 13. Subject with Polypoidal choroidal vasculopathy 14. Active intraocular inflammation or active/suspected ocular or periocular infection in the study eye. 15. History of retinal or intraocular surgery in the study eye in the last three months. 16. Vitreous hemorrhage in the study eye or history of retinal detachment or macular hole (stage 3 or 4) in the study eye. 17. Any other retinal pathology i.e. Central retinal vein occlusion, Central retinal artery occlusion etc. 18. Previous participation in any clinical trial within 1 month before enrollment in the study. 19. Any other condition that in the opinion of Investigator could hamper participation in the study. 20. Pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety of biosimilar Ranibizumab (ENZ105) in patients with Neovascular (Wet) Age related Macular Degeneration (AMD)Timepoint: 3 Months | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of biosimilar Ranibizumab in patients with Neovascular (Wet) Age related Macular Degeneration (AMD)Timepoint: 3 Months | — |
Countries
India
Contacts
Public ContactMr Sandip Kirtane
Alkem Laboratories Ltd.
Outcome results
None listed