Phase 2 Study of ADX-038 in Participants With Geographic Atrophy
Фаза 2 – изследване на ефективността и дозировката
Заболявания:
Geographic Atrophy Secondary to Age-related Macular Degeneration
Спонсор: ADARx Pharmaceuticals, Inc.
Налично на:
БГ
Обобщение
Phase 2 study is designed to assess the efficacy of ADX-038 compared with placebo in participants with GA secondary to AMD. Safety, pharmacokinetics (PK), and pharmacodynamics (PD) will also be assessed.
Кой може да участва
Inclusion Criteria:
* Clinical diagnosis of GA of the macula secondary to AMD
* GA lesions between 2.5 and 12.5 mm2 at screening
* Sufficiently clear ocular media, adequate pupillary dilation and fixation to permit quality fundus imaging in the study eye as described in the protocol
* Willing and able to comply with clinic visits and study-related procedures, including completion of the full series of meningococcal vaccinations and pneumococcal vaccination required per protocol
Exclusion Criteria:
* Has GA secondary to causes other than AMD
* Has active ocular disease that compromises or confounds visual function
* History of surgery for retinal detachment
* Has ocular condition other than GA secondary to AMD
* Use of intravitreal complement inhibitors in study eye
* Hereditary or acquired complement deficiency
* Active viral, bacterial or fungal infection
* Liver injury as evidenced by abnormal liver function tests
* Donating blood
* History of choroidal neovascularization in the study eye