A Multicenter, Proof-Of-Concept Study Of Intravitreal AL-78898A In Patients With Geographic Atrophy (GA) Associated With Age-Related Macular Degeneration (AMD)
Condition: Geographic Atrophy
MeSH terms: Macular Degeneration; Geographic Atrophy; Atrophy
Intervention: Al-78898A; Sham injection
Intervention description: 0.400 milligrams (mg) per 50 microliters (μL) administered as an intravitreal injection; Mock injection administered as an empty hub without needle
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 10.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: No
Keywords: Geographic Atrophy; Age-Related Macular Degeneration; Intravitreal injection

Summary:

      The purpose of this study was to to demonstrate superiority of AL-78898A intravitreal (IVT)
      injections compared to sham injections by assessing mean geographic atrophy (GA) lesion size
      change from baseline at Month 12.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ability to provide informed consent and comply with the protocol.

          -  Diagnosis of bilateral geographic atrophy (GA) of the macula secondary to age-related
             macular degeneration, confirmed within 14 days prior to randomization.

          -  Study eye: Maximum best-corrected visual acuity (BCVA) of 55 letters (20/80 Snellen
             equivalent) and a minimum BCVA of 20 letters (20/400 Snellen equivalent) at screening

          -  BCVA of 20 letters (20/400 Snellen equivalent) or better in the non treated eye at
             screening without conditions other than AMD that, in the opinion of the investigator,
             could cause a rapid loss of vision.

          -  Other protocol-defined inclusion criteria may apply.

        Exclusion Criteria:

          -  Any history or current evidence of exudative ("wet") AMD in study eye.

          -  Retinal disease other than AMD in the study eye.

          -  Any ophthalmologic condition in study eye that reduces the clarity of the media and
             that, in the opinion of the Investigator interferes with ophthalmologic examination,
             such as advanced cataract or corneal abnormalities.

          -  Any ophthalmologic condition in study eye that prevents adequate imaging of the retina
             judged by the site or reading center.

          -  A history or current medical diagnosis of glaucoma or ocular hypertension in study
             eye.

          -  Any ophthalmic condition in study eye that may require surgery during the study
             period.

          -  Current ocular or periocular infection in the study eye.

          -  History of any disease or current use of medication expected to cause systemic or
             ocular immunosuppression, such as RESTASIS®.

          -  History of uveitis or endophthalmitis in the study eye.

          -  History of intraocular surgery (including cataract surgery) in the study eye within 90
             days prior to dosing.

          -  History of intravitreal or periocular injection in the study eye at anytime.

          -  Participation in another interventional clinical study, or use of any experimental
             treatment for AMD or any other investigational new drug within 6 weeks or during
             active period of drug (whichever is longer) prior to the start of study treatment.

          -  History of any medical or psychiatric condition, or substance abuse, that in the
             Investigator's opinion is likely to interfere with the patient's participation in the
             study, or likely to cause serious adverse events during the study.

          -  Women of child bearing potential UNLESS they are using a highly effective method of
             birth control.

          -  Known or suspected allergy or hypersensitivity to fluorescein or other injectables.

          -  Other protocol-defined exclusion criteria may apply.