RECRUITINGPhase 2INTERVENTIONAL
Phase 2 Study of ADX-038 in Participants With Geographic Atrophy
A Phase 2, Randomized, Masked, Placebo-Controlled Study of Subcutaneously Administered ADX-038 in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DRUG
ADX-038
siRNA duplex oligonucleotide
DRUG
Placebo
Saline
Locations (17)
ADARx Clinical Site
Gilbert, Arizona, United States
ADARx Clinical Site
Phoenix, Arizona, United States
ADARx Clinical Site
Beverly Hills, California, United States
ADARx Clinical Site
Huntington Beach, California, United States
ADARx Clinical Site
Poway, California, United States
ADARx Clinical Site
Orlando, Florida, United States
ADARx Clinical Site
Hagerstown, Maryland, United States
ADARx Clinical Site
Erie, Pennsylvania, United States
ADARx Clinical Site
McAllen, Texas, United States
ADARx Clinical Site
Round Rock, Texas, United States
ADARx Clinical Site
San Antonio, Texas, United States
ADARx Clinical Site
The Woodlands, Texas, United States
ADARx Clinical Site
Albury, New South Wales, Australia
ADARx Clinical Site
Parramatta, New South Wales, Australia
ADARx Clinical Site
Rowville, Victoria, Australia
ADARx Clinical Site
Ottawa, Ontario, Canada
ADARx Clinical Site
Toronto, Ontario, Canada