Health Condition 1: H318- Other specified disorders of choroid
Conditions
Interventions
Intervention1: R-TPR-051(RLS-Aflibercept): Route: Intravitreal injection,
Dose: Subjects will be randomised in a 1:1 ratio to receive either R-TPR-051 or Eylea (administered via intravitreal [IVT] i
Sponsors
Reliance Life Sciences Pvt. Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients of age more than or equal to 50 years 2. Active primary or recurrent subfoveal lesions with classic or occult choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) in the study eye 3. Best corrected visual acuity (BCVA) of 20/40 to 20/200 (letter score of 73 to 34, inclusive) using original series Early Treatment Diabetic Retinopathy Study (ETDRS) charts in the study eye at screening and at week 0 (day 1) prior to randomization in the study eye 4. Able to understand the study procedures and the risks involved, willing to provide written Informed Consent, and able to adhere to study schedules and requirements 5. Non-childbearing potential female (e.g., permanently sterilized, postmenopausal [defined as 12 months with no menses without an alternative medical cause prior to Screening]), OR childbearing potential female subjects or male subjects with their (respectively male or female) partners who agree to use at least two forms of appropriate contraception method that can achieve a failure rate of less than 1% per year (e.g., established use of oral, injected, intravaginal, transdermal, or implanted hormonal contraceptive, placement of an intrauterine device or intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner, physical barrier, sexual abstinence) from Screening until 3 months after the last IVT injection of IP
Exclusion criteria
Exclusion criteria: 1. Known history of hypersensitivity or allergic reactions to aflibercept or any of its excipients. 2. Study eye: Sub- or intra-retinal haemorrhage that comprises more than 50% of the entire lesion or presence of blood with the size of 1 DA or more involving the centre of fovea (confirmed by the central reading center during screening) 3. Study eye: Scar, fibrosis, or atrophy involving the centre of the fovea (confirmed by the central reading center during screening) 4. Study eye: Presence of CNV due to other causes, such as ocular histoplasmosis, trauma, multifocal choroiditis, angioid streaks, history of choroidal rupture, or pathologic myopia (confirmed by the central reading center during screening) 5. Study eye: Presence of retinal pigment epithelial tears or rips involving the macula (confirmed by the central reading center during screening) 6. Study eye: Presence of macular hole at any stage (confirmed by the central reading center during screening) 7. Study eye: Any concurrent macular abnormality other than AMD which could affect central vision or the efficacy of IP including but not limited to epiretinal membrane, vitreomacular traction, macular telangiectasia, retinal vascular abnormality, etc. (confirmed by the central reading center during screening) 8. Study eye: Any concurrent ocular condition which, in the opinion of the Investigator, could either confound the interpretation of efficacy and safety of IP (e.g., ocular media opacities such as significant cataract, optic neuropathy etc.) or require medical or surgical intervention during the study period 9. Either eye: History or clinical evidence of diabetic retinopathy (except for mild nonproliferative diabetic retinopathy) or diabetic macular oedema (DME) 10. Study eye: Current vitreous haemorrhage 11. Either eye: Any previous IVT anti-vascular endothelial growth factor (VEGF) treatment (e.g., bevacizumab, ranibizumab, aflibercept, pegaptanib, etc.) 12. Any previous systemic anti-VEGF treatment 13. Study eye: History of treatment involving macula such as macular laser photocoagulation, photodynamic therapy (PDT), transpupillary thermotherapy (TTT), radiation therapy, or any ocular treatment for neovascular AMD 14. Any systemic treatment or therapy (including prescribed herbal medication) to treat neovascular AMD within 30 days prior to randomisation, and such treatment or therapy will not be allowed during the study period. However, dietary supplements, vitamins, or minerals will be allowed. 15. Study eye: History of vitrectomy, scleral bucking (encircling), glaucoma filtration surgery, corneal transplantation, or pan-retinal photocoagulation 16. Study eye: Previous ocular (intraocular and peribulbar) corticosteroids injection/implant within 1 year prior to randomisation 17. Study eye: Topical ocular corticosteroids administered for less than 30 consecutive days or for more than 60 non-consecutive days within 90 days prior to randomisation. 18. Use of systemic corticosteroids for 30 or more consecutive days within 90 days prior to randomisation (inhaled steroid is permitted) 19. Study eye: Any other intraocular surgery (including cataract surgery or Yttrium Aluminium Garnet [YAG] laser posterior capsulotomy in
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to demonstrate the equivalence in efficacy of R-TPR-051 compared to Eylea in subjects with neovascular age-related macular degeneration (AMD)Timepoint: Change from baseline in Best Corrected Visual Acuity (BCVA) at Week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the immunogenicity of R-TPR-051 compared to Eylea: 1. Incidence of anti-drug antibodies (ADAs) to aflibercept 2. Incidence of neutralising antibodies (NAbs) to afliberceptTimepoint: Week 0 (Day 1), Week 4, Week 8, Week 24, Week 32, and Week 40;Quality of LifeTimepoint: baseline to Week 32 and Week 52;Secondary Outcomes : 1. Change from baseline in BCVA over time 2. Proportion of subjects who lost fewer than 15 letters in BCVA 3. Proportion of subjects who gained 15 letters or more in BCVA 4. Change from baseline in central subfield thickness (CST) 5. Proportion of subjects with intra- or sub-retinal fluid on optical coherence tomography 6. Change from baseline in CNV area 7. Proportion of subjects with active CNV leakageTimepoint: Baseline to Week 32 and Week 52;Safety Evaluation: 1. Incidence of ocular adverse events (AEs) or serious ocular AEs 2. Incidence of non-ocular AEs and serious non-ocular AEs 3. Incidence of intraocular inflammation and IOP increase 4. Changes in vital signs and clinical laboratory parametersTimepoint: baseline to end of study (week 52) | — |
Countries
India
Contacts
Public ContactMr Ganesh Bagul
Reliance Life Sciences
Outcome results
None listed