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Набира участници Фаза 2 NCT06990269

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
Интервенции
ADX-038
DRUG
Placebo
DRUG
Места на провеждане 24
Австралия (5)
ADARx Clinical Site
Albury , New South Wales
ADARx Clinical Site
East Melbourne , Victoria
ADARx Clinical Site
Hurstville , New South Wales
ADARx Clinical Site
Parramatta , New South Wales
ADARx Clinical Site
Rowville , Victoria
Канада (2)
ADARx Clinical Site
Ottawa , Ontario
ADARx Clinical Site
Toronto , Ontario
САЩ (17)
ADARx Clinical Site
Austin , Texas
ADARx Clinical Site
Beverly Hills , California
ADARx Clinical Site
Dallas , Texas
ADARx Clinical Site
Erie , Pennsylvania
ADARx Clinical Site
Gilbert , Arizona
ADARx Clinical Site
Hagerstown , Maryland
ADARx Clinical Site
Huntington Beach , California
ADARx Clinical Site
McAllen , Texas
ADARx Clinical Site
Orlando , Florida
ADARx Clinical Site
Phoenix , Arizona
ADARx Clinical Site
Poway , California
ADARx Clinical Site
Reno , Nevada
ADARx Clinical Site
Round Rock , Texas
ADARx Clinical Site
San Antonio , Texas
ADARx Clinical Site
St. George , Utah
ADARx Clinical Site
The Woodlands , Texas
ADARx Clinical Site
Wildwood , Florida
Технически детайли
Статус
Набира участници
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
60 Years
Здрави доброволци
Не
Начална дата
10.11.2025
Крайна дата
30.08.2030
Регистрационен номер
NCT06990269
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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