Table.
Ongoing Phase 2 and 3 Clinical Trials Evaluating GA lesions Registered on ClinicalTrials.gov as of March 1, 2016
| Study Name, NCT Identifier | Study Type | Enrollment | Primary Outcome Measure* |
|---|---|---|---|
| A Study Investigating the Efficacy and Safety of Lampalizumab Intravitreal Injections in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration (CHROMA), NCT02247479 | Phase 3 Interventional | 936 | Change in GA area, as assessed by FAF |
| A Study Investigating the Safety and Efficacy of Lampalizumab Intravitreal Injections in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration (SPECTRI), NCT02247531 | Phase 3 Interventional | 936 | Change in GA area, as assessed by FAF |
| A Phase 2b/3 Multicenter, Randomized, Double-Masked, Dose-Ranging Study Comparing the Efficacy and Safety of Emixustat Hydrochloride (ACU-4429) With Placebo for the Treatment of Geographic Atrophy Associated With Dry Age-Related Macular Degeneration (SEATTLE), NCT01802866 | Phase 2b/3 Interventional | 480 | Change in GA area |
| A Randomized, Double Blind, Placebo Controlled Study Evaluating ORACEA® in Subjects With Geographic Atrophy Secondary to Non-Exudative Age-Related Macular Degeneration (TOGA), NCT01782989 | Phase 2/3 Interventional | 286 | Rate of enlargement in area of geographic atrophy in the study eye during the treatment period |
| A Safety and Efficacy Study of Brimonidine Intravitreal Implant in Geographic Atrophy Secondary to Age-related Macular Degeneration (BEACON), NCT02087085 | Phase 2 Interventional | 300 | Change from baseline in atrophic lesion area in the study eye |
| A Study to Evaluate the Safety and Clinical Response of Subretinal Administration of CNTO 2476 in Participants With Geographic Atrophy (PRELUDE), NCT02659098 | Phase 2 Interventional | 255 | Change in GA lesion growth as measured by FAF (secondary endpoint) |
| Study of APL-2 Therapy in Patients Geographic Atrophy (FILLY), NCT02503332 | Phase 2 Interventional | 240 | Change in square root GA lesion size from baseline, as measured by FAF |
| Clinical Study to Investigate Safety and Efficacy of GSK933776 in Adult Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration, NCT01342926 | Phase 2 Interventional | 184 | Rate of change in area of GA from baseline |
| CLG561 Proof-of-Concept Study as a Monotherapy and in Combination With LFG316 in Subjects With Geographic Atrophy (GA), NCT02515942 | Phase 2 Interventional | 114 | (1) Safety events and (2) change in GA lesion size from baseline, as measured by FAF |
| A Study of Lampalizumab Intravitreal Injections Administered Every Two Weeks or Every Four Weeks to Patients With Geographic Atrophy, NCT02288559 | Phase 2 Interventional | 90 | Mean change in GA area, as measured by FAF |
| The Effect of Metformin on the Progression of Geographic Atrophy in Patients With Age-related Macular Degeneration, NCT02684578 | Phase 2 Interventional | 100 | Change in GA area as measured by FAF |
| Evaluation of Oral Minocycline in the Treatment of Geographic Atrophy Associated With Age-Related Macular Degeneration, NCT02564978 | Phase 2 Interventional | 62 | Rate of change in GA area as measured by FAF |
| A Multicenter, Prospective Epidemiologic Study of the Progression of Geographic Atrophy Secondary to Age-Related Macular Degeneration (PROXIMA-A), NCT02479386 | Observational | 360 | Primary outcomes evaluate visual function; secondary outcomes include measurement of GA area by FAF |
| Prospective Natural History Study of Fundus Autofluorescence Imaging in Age-related Macular Degeneration (FAM-Study) Using Confocal Scanning Laser Ophthalmoscopy, NCT00393692 | Observational | 300 | Change of GA size from baseline, as assessed by FAF |
| An Epidemiologic Study of Disease Progression in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration (Proxima B), NCT02399072 | Observational | 200 | Change in GA area, as assessed by FAF |
| Directional Spread in Geographic Atrophy (DSGA), NCT02051998 | Observational | 130 | Change of GA size from baseline |
Unless otherwise specified as a secondary endpoint