A Phase II Study of RBM-007 Alone and RBM-007 With Eylea® in Subjects With Wet Age-related Macular Degeneration (TOFU)

RIBOMIC

Status and phase: Completed; Phase 2

Conditions: Exudative Age-related Macular Degeneration

Treatments: Drug: RBM-007 Injectable Solution; Drug: Aflibercept; Drug: Sham

Study type: Interventional

Funder types: Industry

Identifiers

NCT04200248

RBM 007-002

Details and patient eligibility

About

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).

Full description

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

Enrollment: 94 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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94 participants in 3 patient groups

Sham + RBM-007

Experimental group

Description:

Sham + RBM-007 intravitreal injection

Treatment:

Drug: RBM-007 Injectable Solution

Drug: Sham

RBM-007 + Aflibercept

Experimental group

Description:

RBM-007 + Aflibercept intravitreal injection

Treatment:

Drug: RBM-007 Injectable Solution

Drug: Aflibercept

Sham + Aflibercept

Active Comparator group

Description:

Sham + Aflibercept intravitreal injection

Treatment:

Drug: Aflibercept

Drug: Sham