OT-551 Antioxidant Eye Drops to Treat Geographic Atrophy in Age-Related Macular Degeneration
Condition: Geographic Atrophy; Age-Related Macular Degeneration; AMD
MeSH terms: Macular Degeneration; Geographic Atrophy; Atrophy
Intervention: OT-551 antioxidant eye drop
Intervention description: 0.45% concentration of OT-551 eye drops were given three times a day on participants with geographic atrophy area for up to three years. Participants had one eye randomized to receive the eye drop and the fellow eye was observed.
Intervention MeSH terms: Ophthalmic Solutions; Antioxidants
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: Retinal Pigment Epithelium; Dynamic Light Scattering (DLS); Visual Acuity Decrease; Intra-ocular Pressure; Autofluorescence of Retina; Age-Related Macular Degeneration; AMD

Summary:

      Othera Pharmaceuticals' Othera (OT)-551 antioxidant eye drop has the potential for chronic
      treatment of the dry form of age-related macular degeneration. This pilot study of up to 10
      eye drop tolerant participants with bilateral geographic atrophy is designed to characterize
      the effect of 0.45% concentration of OT-551 eye drops given 3 times a day on the progression
      of geographic atrophy area over a two-year period. Participants will have one eye randomized
      to receive the eye drop and the fellow eye will be observed only.
    

Eligibility criteria:

        Inclusion Criteria

          1. Participant must understand and sign the protocol's informed consent document (if the
             participant's vision is impaired to the point where it is not possible to read the
             informed consent document, the informed consent document will be read in its entirety
             to the participant).

          2. Participant must be able to administer the eye drops or have a caretaker administer
             the eye drops.

          3. Participant must have geographic atrophy (GA) present in both eyes compatible with
             age-related macular degeneration (AMD). GA is defined as one or more well-defined,
             usually more or less circular patches of partial or complete depigmentation of the
             RPE, typically with exposure of underlying choroidal blood vessels. Even if much of
             the RPE appears to be preserved and large choroidal vessels are not visible, a
             round-ish patch of RPE partial depigmentation may still be classified as early GA. The
             GA in each eye must be able to be photographed in their entirety and not contiguous
             with any areas of peripapillary atrophy, which can complicate area measurements.

          4. Participant must have a steady fixation in the study eye in the foveal or parafoveal
             area and media clear enough for good quality photographs.

          5. Female participants of child bearing potential (those who are not post-menopausal or
             surgically sterile) may participate if they are not lactating and if they agree to
             adequate birth control methods.

        4.5 Exclusion Criteria

          1. Participant is > 60 years of age (to minimize fundus changes from causes other than
             AMD).

          2. Participant is in another investigational study and actively receiving study therapy.

          3. Participant is unable to comply with study procedures or follow-up visits.

          4. Participant has evidence of ocular disease other than AMD in either eye that may
             confound the outcome of the study (e.g., diabetic retinopathy, uveitis, etc.).

          5. Participant has a chronic requirement (e.g., ≥ four weeks at a time) for ocular
             medications for diseases, that in the judgment of the examining physician, are vision
             threatening or may affect the primary outcome (artificial tears are permitted).

          6. Participant has evidence of pseudovitelliform macular degeneration that may confound
             the outcome of the study in either eye.

          7. Participant with evidence of vitreo-retinal traction maculopathy that may confound the
             outcome of the study in either eye.

          8. Participant has a history of laser, photodynamic therapy (PDT), intravitreal injection
             of any agent (e.g., anti-VEGF, triamcinolone, etc.), or any previous treatment for AMD
             other than AREDS or equivalent supplement formulation in the study eye.

          9. Participant has had a vitrectomy, penetrating keratoplasty, trabeculectomy or
             trabeculoplasty.

         10. Participant has undergone lens removal in the last three months.

         11. Participant is on chemotherapy.

         12. Participant is on ocular or systemic medications known to be toxic to the lens,
             retina, or optic nerve.

         13. Participant with a history of malignancy that would compromise the 2-year study
             survival.

         14. Participant with a history of ocular Herpes simplex virus.

         15. Participant with a history of or demonstration of allergy to benzakonium chloride, a
             preservative agent used in the eye drop.