A Phase II Study of RBM-007 Alone and RBM-007 With Eylea® in Subjects With Wet Age-related Macular Degeneration
Condition: Exudative Age-related Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: RBM-007 Injectable Solution; Aflibercept; Sham
Intervention description: RBM-007 Injectable Solution; EYLEA® (aflibercept) Injection, for Intravitreal Use; Sham intravitreal injection
Intervention MeSH terms: Aflibercept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 94.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: No
Keywords: Fibrosis; Edema; Neovascularization

Summary:

      This is a multicenter, active-controlled, double masked study assessing the safety, efficacy
      and durability of four monthly intravitreal (IVT) injections of RBM-007 monotherapy, and four
      monthly RBM-007 injections in combination with Eylea® dosed at every other month, compared to
      Eylea® monotherapy dosed at every other month in approximately eighty-one subjects with
      exudative age-related macular degeneration (AMD).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Provide signed written informed consent.

          2. Male or female 55 years of age or older on the date of signing the consent and able
             and willing to comply with all treatment and study procedures.

          3. Diagnosis of exudative age-related macular degeneration in the study eye, for which
             previous standard treatment with intravitreal anti-vascular endothelial growth factor
             agents (at least 4 injections over the past 8 months) has demonstrated incomplete
             resolution of exudation, as assessed by spectral domain optical coherence tomography.

          4. Presence of macular edema or subretinal fluid.

          5. Absence of central atrophy or retinal epithelial tear in the fovea or any condition
             preventing visual acuity improvement in the study eye.

          6. Visual acuity of 78 to 24 letters (20/32 to 20/320) in the study eye.

          7. Visual acuity of 24 letters (20/320) or better in the fellow eye.

          8. Reasonably clear media and some fixation in the study eye to allow for good quality
             tomography and fundus photography

        Exclusion Criteria:

          -  Ocular:

               1. Use of any of the following treatments or anticipated use of any of the following
                  treatments to the study eye:

                    1. Any intravitreal treatment within 4 weeks prior to Baseline (Visit 1).

                    2. Intravitreal or periocular corticosteroid, within 90 days prior to Visit 1
                       (Day 1) and throughout the study.

                    3. Fluocinolone acetonide intravitreal implant, within 12 months prior to Visit
                       1 (Day 1) and throughout the study.

                    4. Visudyne® photodynamic therapy, within 90 days prior to Visit 1 (Day 1) and
                       throughout the study.

               2. Uncontrolled or advanced glaucoma, evidenced by an intraocular pressure of > 21
                  mmHg or cup/disc ratio > 0.8 while on medical therapy, or chronic hypotony (< 6
                  mmHg) in the study eye.

               3. Evidence of any other ocular disease other than wet age-related macular
                  degeneration in the study eye that may confound the outcome of the study

               4. History of vitrectomy in the study eye.

               5. Need for ocular surgery in the study eye during the course of the study.

               6. YAG laser capsulotomy within 30 days prior to Visit 1 (Day 1) in the study eye.

               7. Intraocular surgery, including lens removal or laser, within 90 days prior to
                  Visit 1 (Day 1) in the study eye.