Clinical trial NCT04200248: A Phase II Study of RBM-007 Alone and RBM-007 With Eylea® in Subjects With Wet Age-related Macular Degeneration
Official title: A Multi-Center, Randomized, Double Masked and Active Controlled Phase II Study Assessing the Efficacy and Safety of Intravitreal Injections of RBM-007 Monotherapy and RBM-007 in Combination With Eylea® Compared to Eylea® Monotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Exudative Age-related Macular Degeneration
Keywords: Fibrosis
Edema
Neovascularization
Lead sponsor: Ribomic USA Inc
Sponsor class: INDUSTRY
First posted: 2019-12-16
Enrollment: 94
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed description: RBM-007 is a novel oligonucleotide-based aptamer having potent anti-FGF2 activity and anti-VEGF-expression activity

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.

Primary outcomes:
measure: Visual Acuity - Continuous
timeFrame: Week 16
Secondary outcomes:
measure: Visual Acuity - Categorical
timeFrame: Week 16
measure: Macular Thickness Change
timeFrame: Week 16
measure: Macular Volume Change
timeFrame: Week 16
measure: Fibrosis Change
timeFrame: Week 16
measure: Safety - Ocular
timeFrame: Week 20
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Retinal Research Institute, LLC
state: Arizona
city: Sacramento
country: United States
facility: Retinal Consultants Medical Group
state: California
city: Walnut Creek
country: United States
facility: Bay Area Retina Associates
state: California
city: Coral Springs
country: United States
facility: Advanced Research, LLC
state: Florida
city: Marietta
country: United States
facility: Georgia Retina, P.C.
state: Georgia
city: Indianapolis
country: United States
facility: Raj K. Maturi, M.D., P.C.
state: Indiana
city: McAllen
country: United States
facility: Valley Retina Institute, PA
state: Texas
city: San Antonio
country: United States
facility: Medical Center Ophthalmology Associates
state: Texas
Study officials:
affiliation: RIBOMIC USA
name: Padma Bezwada, Ph.D.
role: STUDY_DIRECTOR
References: