Neovascular Age-Related Macular Degeneration
Conditions
Interventions
The study settings include Durdans Hospital, Colombo 03, National Eye Hospital, Colombo 10, The National Hospital Kandy, Kandy, Jaffna Teaching Hospital, Jaffna and Sri Jayewardenepura General Hospita
Sponsors
Lupin Limited (Biotechnology Division)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Ambulatory male or female participants with age greater than or equal to 50 years at the time of screening who are capable of understanding and giving written informed consent. 2. Primary or recurrent (anti- Vascular Endothelial Growth Factor (VEGF) naïve) active Choroidal neovascularization (CNV@) lesions involving the foveal center secondary to AMD in any one of the eyes. 3. Best Corrected Visual Acuity (BCVA) in the study eye, using Early Treatment Diabetic Retinopathy Study (ETDRS) testing, between 20/40 and 20/200 (Snellen equivalent), both inclusive, before pupil dilation. 4. Willingness and ability to undertake all scheduled visits and assessments. 5. Females, who are of non-child bearing potential (surgically sterile or menopausal), OR, if of child bearing potential using effective birth control measures and non-pregnant and non-lactating during the study and 3 months after the last dose.
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to ranibizumab or any of the components of study medication. 2. Known history of allergy to fluorescein dye. 3. Scar, fibrosis, or atrophy involving the center of the fovea in the study eye as assessed by FA (confirmed by independent central reading center). 4. Subretinal hemorrhage in the study eye that involves the center of the fovea, the size of the hemorrhage is either greater than or equal to 50% of the total lesion area or greater than or equal to 1-disc area in size (confirmed by independent central reading center). 5. Total lesion area greater than or equal to 12.0-disc areas (DA) in size (including blood, scars, and neovascularization) as assessed by FA in the study eye (confirmed by independent central reading center). 6. History of vitrectomy, submacular surgery, or other surgical intervention for AMD in the study eye. 7. Employees of clinical study sites, individuals directly involved with the conduct of the study or immediate family members thereof, prisoners, and persons who are legally institutionalized. 8. Any other pathology involving the CNV lesion like retro-foveolar atrophy or permanent structural damage to fovea or fibrosis/ hemorrhage involving fovea > 50% of lesion area of study eye that can affect the efficacy of drug. 9. Vitreous hemorrhage or history of rhegmatogenous retinal detachment, retinal pigment epithelial tears or rips involving the macula or macular hole (stage 1 to 4) in the study eye as assessed by FA (confirmed by independent central reading center). 10. Uncontrolled glaucoma as evident by progressive damage to optic nerve or visual fields despite optimum therapy; or steroid-induced glaucoma with continued use of steroids that requires IOP-lowering treatment. 11. History of serious complications following surgery in the study eye within 1 year prior to randomization. 12. Previous treatment with intravenous or intravitreal anti-VEGF agents such as Bevacizumab, Ranibizumab, Aflibercept, Pegaptanib, Brolucizumab in either of the eyes. 13. Previous external beam radiation or any laser therapy photocoagulation/ thermal laser thermotherapy/verteporfin photodynamic therapy (PDT) involving the foveal center in the study eye within 5 years prior to randomization. 14. Previous treatment with verteporfin photodynamic therapy (PDT), thermal laser, transpupillary thermotherapy (except subfoveal) in the study eye or use of protein kinase C inhibitors within 3 months prior to randomization. 15. Previous treatment with intravitreal steroids (e.g., triamcinolone, anecortave acetate) in the study eye within 3 months prior to randomization. 16. Previous treatment with intravitreal steroid implant (like Ozurdex®) within 6 months prior to randomization. 17. Concurrent use of systemic anti-VEGF agents. 18. Intraocular surgery (including cataract surgery) in the study eye within 3 months prior to randomization. 19. Concurrent treatment with an investigational drug or device in the non-study eye. 20. Previous participation in any studies of investigational drugs within 30 days or as prescribed in that study (whichever is later) preceding the initial study treatment. 21. Patients who have DME and/or background or proliferative retinopathy will be excluded. Likewise, any with significant posterior subcapsular cataract (PSC) should be excluded 22. CNV in the study eye due to causes other than AMD such as histoplasmosis, trauma, or pathological myopia etc. or CNV lesion not likely to respond to rani
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in BCVA from baseline in the study eye at the end of 12, months assessed with the ETDRS chart [Time Frame: 12 months ] | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in BCVA from baseline in the study eye accessed with the ETDRS chart [Time Frame: 3 months, 6 months and 9 months] Proportion of patients with anti-drug antibodies [ Time Frame: 1, 3, 6, 9, and 12 months ] Adverse Events (AEs) (Number of patients with clinically significant ophthalmic examination findings) [ Time Frame: Baseline to 12 months ] Physical & systemic examination (Number of patients with clinically significant physical & systemic examination findings) [ Time Frame: Baseline to 12 months ] Vital Signs (Number of patients with clinically significant vital signs findings) [ Time Frame: Baseline to 12 months ] ECGs (Number of patients with clinically significant ECG findings) [ Time Frame: Baseline to 12 months ] Clinical Laboratory Tests (Number of patients with clinically significant laboratory test findings) [ Time Frame: Baseline to 12 months ] Ophthalmic examination (Number of patients with clinically significant ophthalmic examination findings) [ Time Frame: Baseline to 12 months ] | — |
Countries
Bulgaria,Hungary,India,Poland,Slovakia,Ukraine,United States
Contacts
Public ContactDr Charith Fonseka
Consultant Eye surgeon
Outcome results
None listed