Age Related Macular Degeneration (AMD) Clinical Trial
Official title:
Development of Novel Clinical Endpoints for Interventional Clinical Trials With a Regulatory and Patient Access Intention in Patients With Intermediate Age-related Macular Degeneration (AMD)
Development of novel clinical endpoints for interventional clinical trials with a regulatory and patient access intention in patients with intermediate age-related macular degeneration (AMD) - MACUSTAR
The purpose of the MACUSTAR clinical study is to develop novel clinical endpoints for clinical trials with a regulatory and patient access intention in patients with intermediate age-related macular degeneration (iAMD). Additional objectives are to characterize the visual impairment in iAMD and its progression, as well as identify risk factors for progression to late stage AMD. Moreover, MACUSTAR aims to optimize and standardize most relevant existing and/or rapidly available clinical endpoints in: - visual functional outcomes measures - structural outcomes measures - patient reported outcomes measures (PROMs) The study will be composed by two parts: - a cross-sectional part to technically evaluate the functional and structural outcome measures to support a biomarker qualification by regulatory authorities and payers; and - a longitudinal part to assess the prognostic power of changes in retinal sensitivity (as measured by microperimetry) for progression from iAMD to late AMD (nAMD and GA). ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02121353 -
Safety Study of PF582 Versus Lucentis in Patients With Age Related Macular Degeneration
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05932069 -
Active AMD Study to Improve Function in Veterans
|
N/A | |
| Terminated |
NCT00327470 -
An Open Label Trial to Investigate Macugen for the Preservation of Visual Function in Subjects With Neovascular AMD
|
Phase 4 | |
| Enrolling by invitation |
NCT05481827 -
ORACLE: A Long-term Follow-up Study to Evaluate the Safety of GT005 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration Treated in a Gyroscope-sponsored Antecedent Study
|
Phase 2 | |
| Completed |
NCT01542866 -
A 16 Week Evaluation of the Novartis Health Management Tool (HMT) in Age Related Macular Degeneration (AMD)
|
N/A | |
| Completed |
NCT02464956 -
Production of iPSC Derived RPE Cells for Transplantation in AMD
|