Health Condition 1: H353- Degeneration of macula and posterior pole
Conditions
Interventions
Intervention1: ENZ105: It will be administered at the dose of 0.5 mg by intravitreal injection every 4 weeks for a total of 12 weeks (03 doses) under aseptic conditions.
Control Intervention1: Innova
Sponsors
Enzene Biosciences Limited
Alkem Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Willing to provide voluntary written informed consent.2.Male or female participant with age greater than or equal to 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. Prior treatment with any anti-VEGF therapy in last 6 months 6. Subfoveal fibrosis or Subfoveal atrophy in the study eye. 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 over the study period (e.g. diabetic retinopathy, cataract, uncontrolled glaucoma, 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. Known history of peripheral vasculopathy, peripheral arterial disease within 01 year of study participation 12. Subject with Polypoidal choroidal vasculopathy. 13.Active intraocular inflammation or active/suspected ocular or periocular infection in the study eye. 14. History of retinal or intraocular surgery in the study eye in the last three months. 15. Vitreous hemorrhage in the study eye or history of retinal detachment or macular hole (stage 3 or 4) in the study eye. 16. Any other retinal pathology i.e. Central retinal vein occlusion, Central retinal artery occlusion etc. 17. Pregnant or breastfeeding. 18. Subjects with suspected signs and symptoms of COVID-19/ confirmed novel coronavirus infection (COVID-19) or with history of travel / contact with any COVID-19 positive patient/isolation/quarantine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the efficacy of ENZ105 (Enzene) with Innovator Ranibizumab in subjects with Neovascular (Wet) Age related Macular Degeneration (AMD) by Visual acuity testTimepoint: Percentage of subjects who loose 15 letters in visual acuity in the study eye at week 12 compared to baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To assess the immunogenicity of ENZ105 (Enzene) versus Innovator Ranibizumab by assessment of anti-Ranibizumab antibody 2.Safety and tolerability of the investigational product. Timepoint: 1.Percentage of subjects who gain greater or equal to 15 letters in visual acuity in the study eye at week 12 compared to baseline 2.Mean change in best corrected visual acuity (BCVA) from baseline in the study eye at week 12 | — |
Countries
India
Contacts
Public ContactDr Vinayaka Shahavi
Alkem Laboratories Limited
Outcome results
None listed