Health Condition 1: H475- Disorders of other visual pathways
Conditions
Interventions
Intervention1: Aflibercept intravitreal (IVT) injection: Subjects will receive 2 mg (0.05 mL) of SBPL-Aflibercept by intravitreal (IVT)injection on Day 0 and subsequent IVT injection of 2 mg (0.05 mL)
Sponsors
Shilpa Biologicals Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or female participant between 45 and 75 years of age, both inclusive, at the time of screening. 2.Subject with active primary or recurrent subfoveal lesion with CNV (choroidal neovascularization) secondary to AMD in the study eye. (Please note: Only one eye will be considered for study. If both eyes are eligible, the one with the better visual acuity will be selected for treatment unless, based on medical reasons, the investigator deemed the other eye to be more appropriate for treatment. If both eyes have similar visual acuity and similar medical reasons, then right eye will be selected) 3.Subjects having a best corrected visual acuity equivalent to Snellen acuity of 20/40 to 20/320 in the study eye, using Early Treatment Diabetic Retinopathy Study (ETDRS) chart for testing at 4 meters. 4.Central retinal thickness of >=300 µm in the study eye as measured by SD-OCT at screening. 5.Subjects able to understand and voluntarily provide written informed consent before screening, following an explanation of the nature and purpose of this study.
Exclusion criteria
Exclusion criteria: 1. Prior treatment with verteporfin or photodynamic therapy in the study eye (except for extrafoveal laser photocoagulation in the study eye) and,or non study eye within past 3 months before study entry. 2. Prior treatment with systemic or intravitreal anti-vascular endothelial growth factor (VEGF) agents within past 6 months before study entry in the study eye. 3. Any prior treatment with systemic or intravitreal anti-VEGF agents in the fellow eye within past 3 months before study entry. 4. Total lesion size grater than 30.5 mm2, including blood, scars, and neovascularization as assessed by fluorescein angiography (FA) in the study eye. 5. Presence of aphakia in study eye. 6. Uncontrolled hypertension defined as systolic blood pressure (BP) grater than 180 mmHg or diastolic BP grater than 100 mmHg under appropriate antihypertensive treatment. 7. Subject with prior treatment within past 3 months before study entry or current treatment with medication which might cause significant detrimental effect in retina i.e., hydroxychloroquine, chloroquine, vigabatrin or amiodarone etc. 8. Prior vitrectomy or laser surgery of the macula (including photodynamic therapy or focal laser photocoagulation) within 1 month before study entry in the study eye. 9. Scar or fibrosis, making up grater than 70percentage of the total lesion in the study eye. 10. Scar, fibrosis, or atrophy involving the centre of the fovea. 11. Sub- or intra-retinal haemorrhage that comprises more than 50% of the entire lesion or presence of blood with the size of 1 DA (disc area) or more involving the centre of fovea in the study eye. 12. History of CNV in either of the two eye due to causes other than AMD such as pathologic myopia (spherical equivalent of 8 diopters or more negative or axial length of 25 mm or more), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, or multifocal choroiditis in the study. 13. Retinal pigment epithelial tear involving the macula in the study eye. 14. Any concurrent intraocular condition in the study eye that could either require medical or surgical intervention during the 3 months study period or that could contribute to a loss of best corrected visual acuity over the 3 months 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. 15. Active intraocular inflammation or ongoing infection in the study eye. 16. Vitreous hemorrhage in the study eye or history of rhegmatogenous retinal detachment or macular hole of Stage 2 and above in the study eye. 17. Any other retinal pathology i.e. Central retinal vein occlusion (CRVO), Central retinal artery occlusion (CRAO) etc. 18. Subjects found positive for any of the serology test for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV). 19. Known hypersensitivity to aflibercept or any of the components of study medication. 20. Previous participation in any clinical trial within 1 month before the entry of the study. 21. Any other condition that in the opinion of investigator could hamper participation in the study and suspected or confirmed poor compliance as per investigators judgment, in completing the trial and follow up tha
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects who loose grater than 15 letters (approximately 3 lines) from baseline visual acuity in the study eye.Timepoint: Baseline, Visit 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects who gain grater than or equal 15 letters (approximately 3 lines) from baseline visual acuity in the study eye [Time Frame: Day 84] Mean change in best corrected visual acuity (BCVA) in the study eye from baseline to end study visit [Time Frame: Day 84] Proportions of subjects with incidence of Antidrug Antibodies (ADA) [Time Frame: At baseline and Day 84] Proportions of subjects with treatment-emergent adverse events, adverse events of interest (EOIs), and serious adverse events [Time Frame: Up to Day 84]Timepoint: Day0 to Day84 | — |
Countries
India
Contacts
Public ContactP Veerendra Kumar
Shilpa Medicare Limited
Outcome results
None listed