Macular Degeneration Clinical Trial
Official title:
A Phase III Double-Blind, Parallel Group, Multicenter Study to Compare the Efficacy and Safety of Xlucane Versus Lucentis® in Patients With Neovascular Age-Related Macular Degeneration
The objectives of the study are to demonstrate the equivalence of Xlucane to Lucentis® in treatment of subjects with wet (ie, neovascular) age-related macular degeneration (wAMD).
This is a phase III multicenter, double-masked, randomized, parallel group study in subjects with wAMD. Approximately 580 subjects will be enrolled and randomized in a 1:1 ratio to receive either Lucentis® or the investigational product, Xlucane in the study eye once every 4 weeks for 52 weeks. The study eye will be defined as the eye meeting the enrollment criteria. The assigned study drug will be administered as an ophthalmic intravitreal (IVT) injection. A subgroup of 60 subjects at a select number of participating sites will be sequentially asked to participate in an evaluation of PK. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06262737 -
Single-center Study Measuring OSDI Dry Eye Score in Patients Undergoing an Anti-VEGF Induction Protocol
|
||
| Completed |
NCT02540954 -
Efficacy and Safety of Two Different Aflibercept Regimens in Subjects With Neovascular Age-related Macular Degeneration (nAMD)
|
Phase 3 | |
| Completed |
NCT00385333 -
Metabolic Mapping to Measure Retinal Metabolism
|
Phase 2 | |
| Completed |
NCT02510794 -
Study of the Efficacy and Safety of the Ranibizumab Port Delivery System for Sustained Delivery of Ranibizumab in Patients With Subfoveal Neovascular Age-Related Macular Degeneration
|
Phase 2 | |
| Completed |
NCT02181504 -
A Study of Abicipar Pegol in Japanese Patients With Neovascular Age-related Macular Degeneration
|
Phase 2 | |
| Completed |
NCT02390245 -
Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study
|
N/A | |
| Terminated |
NCT02228304 -
Study of the Intravitreal Implantation of NT-503-3 Encapsulated Cell Technology (ECT) for the Treatment of Recurrent Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD)
|
Phase 1/Phase 2 | |
| Recruiting |
NCT01521065 -
An Open-label Study to Evaluate the Clinical and Economic Benefits of I-Ray in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration
|
Phase 2 | |
| Completed |
NCT01204541 -
A Single-Center Pilot Study to Assess Macular Function
|
N/A | |
| Completed |
NCT00769392 -
Pilot Study: A Randomized Trial Of Anesthetic Agents For Intravitreal Injection
|
N/A | |
| Completed |
NCT00533520 -
Evaluation of Dosing Interval of Higher Doses of Ranibizumab
|
Phase 4 | |
| Completed |
NCT00536016 -
A Phase 1 Safety Study of Single and Repeated Doses of JSM6427 (Intravitreal Injection) to Treat AMD
|
Phase 1 | |
| Withdrawn |
NCT00538538 -
Subretinal Lucentis for Hemorrhagic Age-related Macular Degeneration (AMD)
|
Phase 1 | |
| Terminated |
NCT00403442 -
Bevacizumab in Combination With Verteporfin Reduced and Standard Fluence in the Treatment of Hemorrhaged Lesions in Neovascular AMD
|
Phase 1 | |
| Recruiting |
NCT00157976 -
Double-Masked Study of Photrex (Rostaporfin) Photodynamic Therapy in the Treatment of Age-Related Macular Degeneration
|
Phase 3 | |
| Completed |
NCT00239928 -
Clinical Study Of Pegaptanib Sodium (EYE001) For Wet-Type Age-Related Macular Degeneration
|
Phase 2 | |
| Completed |
NCT00211458 -
Treatment of Age-Related Macular Degeneration With Anecortave Acetate
|
Phase 2 | |
| Completed |
NCT00242580 -
A Safety and Efficacy Study Comparing the Combination Treatments of Verteporfin Therapy Plus One of Two Different Doses of Intravitreal Triamcinolone Acetonide and the Verteporfin Therapy Plus Intravitreal Pegaptanib
|
Phase 3 | |
| Completed |
NCT00095433 -
Extension Study of rhuFab V2 in Subjects With Neovascular Age-Related Macular Degeneration (AMD)
|
Phase 3 | |
| Completed |
NCT00006202 -
Lutein for Age-Related Macular Degeneration
|
Phase 2 |