Health Condition 1: H353- Degeneration of macula and posterior pole
Conditions
Interventions
Intervention1: Aflibercept Injection, 40 mg/mL: Intravitreal injection of Aflibercept
at a dose of 2 mg every 4 weeks for initial 03 injections followed
by one injection every 8 weeks if required
Con
Sponsors
Sun Pharmaceutical Industries Limited
Sun Pharmaceutical Industries Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Ambulatory patients of either gender aged greater than or equal to 50 years at the time of screening and who are capable of understanding and giving written informed consent. 2. Active primary subfoveal CNV lesions secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye. Active CNV indicates presence of leakage and intra-or sub-retinal fluid detected on FA. 3. Best corrected visual acuity (BCVA), using ETDRS chart, (20/40 to 20/320 Snellen equivalent) in the study eye before pupil dilation screening and randomization 4. Women of childbearing potential must have a negative urine pregnancy test at screening and agree to use highly effective methods of contraception to prevent pregnancy throughout the study and for at least 3 months after last injection 5. Male participants must have had a successful vasectomy (confirmed azoospermia) or must practice highly effective contraception throughout the study period and for at least 3 months after last injection and their female partners must meet the criteria above no. 5.
Exclusion criteria
Exclusion criteria: Ocular condition in the study eye: 1. Total lesion size greater than 12 DA (30.5 mm2), including blood, scars and neovascularization) as assessed by FA in the study eye. 2. A subretinal haemorrhage involving the centre of the fovea equal to or more than one DA in size or, if the size of the haemorrhage is greater than equal to 50%, of the total lesion area 3. Scar or fibrosis, making up greater than 50% of total lesion or involving the centre of fovea in the study eye. 4. Presence of or history of retinal detachment or retinal pigment epithelial tears or rips involving the macula in the study eye. 5. History of vitreous haemorrhage within 4 weeks prior to screening in the study eye. 6. History of macular hole of stage 2 and above in the study eye. 7. Aphakia or absence of posterior capsule 8. History or presence of corneal dystrophy in the study eye. 9. Significant media opacities, including cataract, in the study eye that might interfere with visual acuity, assessment of safety, or fundus photography. 10. Any concurrent intraocular condition in the study eye that, in the opinion of the Investigator, could require either medical or surgical intervention during the study or may increase the risk of the patient or may interfere with the injection procedure or with evaluation of efficacy or safety. 11. History or clinical evidence of diabetic retinopathy, diabetic macular edema or any other vascular disease affecting the retina, other than AMD, in either eye 12. Presence of active ocular or periocular infection in either eye. 13. Any ocular or periocular infection within the last 3 weeks prior to Screening in either eye. 14. Presence or history of uveitis or scleromalacia in either eye. 15. Uncontrolled glaucoma (defined as IOP greater than equal to 25 mmHg) in the either eye 16. Previous treatment with laser photocoagulation, photodynamic therapy (PDT), transpupillary thermotherapy (TTT), radiation therapy, intravitreal drug delivery (steroids or device implantation) or any prior ocular treatment for neovascular AMD in the study eye 17. Any prior treatment with anti VEGF therapy in the study eye 8. Any other intraocular surgery (including cataract surgery or Yttrium Aluminium Garnet [YAG] laser posterior capsulotomy in association with prior posterior chamber intraocular lens [IOL] implantation) or periocular surgery within 90 days prior to randomisation in the study eye 19. Prior trabeculectomy or other filtration surgery in the study eye 20. Prior vitrectomy in the study eye. 21. History of any pan retinal photocoagulation in the study eye 22. Any previous systemic treatment for neovascular AMD except dietary supplements or vitamins. 23. Use of any herbal medication for neovascular AMD within 30 days of screening. 24. Current use of medications known to be toxic to the lens, retina, or optic nerve (including but not limited to deferoxamine, chloroquine/hydroxychloroquine, tamoxifen, phenothiazines, vigabatrin, ethambutol, etc.) 25. History of retinal detachment or treatment or surgery for retinal detachment in the study eye. 26. History or presence of any other disease or laboratory findings or clinical evaluation finding that contraindicates the use of an investigational drug or that might affect interpretation of the results of the study or render the pati
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients losing fewer than 15 letters (approximately 3 lines) in BCVATimepoint: From baseline (pre dose Day 1) to Week 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients losing fewer than 15 letters (approximately 3 lines) in BCVATimepoint: From baseline (pre dose Day 1) to Week 24.;Change from baseline in BCVA as measured by ETDRS letter scoreTimepoint: from baseline to Week 4, Week 8 Week12, Week 16, Week 20 And Week 24;Proportion of patients who gain at least 15 letters of vision on the ETDRS chartTimepoint: baseline to Week 4, Week 8 Week 12, Week 16, Week 20 And Week 24;Change in central retinal thickness in the study eye assessed by OCTTimepoint: from baseline to Week 24;Change in total NEI VFQ-25 scoreTimepoint: from baseline to Week 4, Week 8 Week 12, Week 16, Week 20 and Week 24;Incidence of TEAEsTimepoint: throughout the study;Proportion of patients with ADA and NAbTimepoint: at baseline and Week 24 | — |
Countries
India
Contacts
Public ContactChaitali Bornare
Sun Pharma Laboratories Limited
Outcome results
None listed