QA102 Phase II Study in Subjects With Dry AMD

Korábbi kezelés

• Subject received an active investigational drug within 6 weeks (or 5 half-lives of the active, whichever is longer) prior to screening for this QA102 study.
• Subject has ever received gene therapy (for any condition).
• Subject had major surgery within 30 days prior to Screening.
  • Specific to Study Eye:
• Subject has ever received, whether in an interventional trial or by prescription, an FDA- approved treatment for GA. Use of such treatment during the QA102 study period also is prohibited. (Study Eye Only)
  • Specific to Fellow Eye:
  • Subject has monocular vision impairment, defined as having no light perception in the fellow eye with adequate vision in the study eye.
  • Specific to Either Eye:
• Subject had intraocular surgery with lens replacement within 3 months of Screening.

Más betegség

• Subject has a clinically significant systemic disease that might interfere with the study, in the judgment of the Investigator.
• Subject has any ophthalmic condition that could require surgery during the study period.
• Subject has an ocular condition that might affect adequate imaging of the retina and/or or alter visual acuity.

Életkor

• Subject is unwilling to stop intake of Age-Related Eye Disease Studies (AREDS) vitamins for the duration of the study.

Egyéb

• Subject has large GA, subfoveal GA, or active or inactive CNV, as confirmed by the CRC.
• Subject has GA or CNV due to causes other than AMD that that developed between Visit 1 (Screening) and Visit 2 (Randomization).
• Subject has endophthalmitis.
• Subject has a hemorrhagic or serous pigment epithelial detachment (PED) within 500 µm of the foveal center point, to be confirmed by the CRC.
• Subject has had retinal procedures or surgeries, or has a retinal pathology, such as a macular hole.
• Subject has aphakia or absence of the posterior capsule.

• Subject must be able to understand and willing to sign a written informed consent form (ICF) prior to the initiation of any study-specific procedures.
• Subject must be age ≥50 years at the time of informed consent.
• Subject must be able to take oral medications and willing to record daily adherence to taking their assigned capsules.
• Subject must have adequate hematologic function, hepatic function, renal function and coagulation profile as defined in the protocol.
• Subject must be willing and able to comply with study procedures and examinations.
  • Specific to the Study Eye:
• Subject must have one of the following:
  • extensive intermediate-size drusen, or at least 1 large drusen, or
  • GA ((not involving the foveal center point) secondary to AMD, with very limited aggregate size of total GA(s), as defined in the protocol.
• Subject must be able to correctly identify ≥35 ETDRS letters (approximately 20/200 Snellen equivalent).
  • Specific to Fellow Eye:
  • \- Subject must have a diagnosis of advanced AMD (evidence of GA and/or CNV), to be confirmed by the CRC.
  • Specific to Both Eyes:
  • \- Subject must have visualizable retina, clear ocular media, and adequate pupillary dilation to ensure high-quality fundus imaging.