A Phase II Study of RBM-007 Alone and RBM-007 With Eylea® in Subjects With Wet Age-related Macular Degeneration (TOFU)
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ClinicalTrials.gov Identifier: NCT04200248 |
Recruitment Status :
Recruiting
First Posted : December 16, 2019
Last Update Posted : February 17, 2020
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Condition or disease | Intervention/treatment | Phase |
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Exudative Age-related Macular Degeneration | Drug: RBM-007 Injectable Solution Drug: Aflibercept Drug: Sham | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 81 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | December 2, 2019 |
Estimated Primary Completion Date : | June 30, 2021 |
Estimated Study Completion Date : | June 30, 2021 |

Arm | Intervention/treatment |
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Experimental: Sham + RBM-007
Sham + RBM-007 intravitreal injection
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Drug: RBM-007 Injectable Solution
RBM-007 Injectable Solution Drug: Sham Sham intravitreal injection |
Experimental: RBM-007 + Aflibercept
RBM-007 + Aflibercept intravitreal injection
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Drug: RBM-007 Injectable Solution
RBM-007 Injectable Solution Drug: Aflibercept EYLEA® (aflibercept) Injection, for Intravitreal Use |
Active Comparator: Sham + Aflibercept
Sham + Aflibercept intravitreal injection
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Drug: Aflibercept
EYLEA® (aflibercept) Injection, for Intravitreal Use Drug: Sham Sham intravitreal injection |
- Visual acuity - continuous [ Time Frame: Week 16 ]Mean change in Best Corrected Visual Acuity from Baseline
- Visual acuity - categorical [ Time Frame: Week 16 ]Proportion of patients gaining more than 15 letters as measured by Best Corrected Visual Acuity from Baseline
- Macular thickness change [ Time Frame: Week 16 ]Change from Baseline in Central Subfield Thickness by spectral domain optical coherence tomography
- Macular volume change [ Time Frame: Week 16 ]Change from Baseline in macular volume by spectral domain optical coherence tomography
- Fibrosis change [ Time Frame: Week 16 ]Change from Baseline in sub-retinal hyper-reflective material by spectral domain optical coherence tomography
- Safety - Ocular [ Time Frame: Week 20 ]Ocular examination (biomicroscopy and ophthalmoscopy)
- Safety - Systemic - Heart rate [ Time Frame: Week 20 ]Change in heart rate (beats per minute)
- Safety - Systemic - Blood pressure [ Time Frame: Week 20 ]Change in systolic and diastolic blood pressure (millimeters of mercury)

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Ages Eligible for Study: | 55 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Provide signed written informed consent.
- 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.
- 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.
- Presence of macular edema or subretinal fluid.
- Absence of central atrophy or retinal epithelial tear in the fovea or any condition preventing visual acuity improvement in the study eye.
- Visual acuity of 78 to 24 letters (20/32 to 20/320) in the study eye.
- Visual acuity of 24 letters (20/320) or better in the fellow eye.
- Reasonably clear media and some fixation in the study eye to allow for good quality tomography and fundus photography
Exclusion Criteria:
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Ocular:
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Use of any of the following treatments or anticipated use of any of the following treatments to the study eye:
- Any intravitreal treatment within 4 weeks prior to Baseline (Visit 1).
- Intravitreal or periocular corticosteroid, within 90 days prior to Visit 1 (Day 1) and throughout the study.
- Fluocinolone acetonide intravitreal implant, within 12 months prior to Visit 1 (Day 1) and throughout the study.
- Visudyne® photodynamic therapy, within 90 days prior to Visit 1 (Day 1) and throughout the study.
- 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.
- 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
- History of vitrectomy in the study eye.
- Need for ocular surgery in the study eye during the course of the study.
- YAG laser capsulotomy within 30 days prior to Visit 1 (Day 1) in the study eye.
- Intraocular surgery, including lens removal or laser, within 90 days prior to Visit 1 (Day 1) in the study eye.
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04200248
Contact: Yusuf Ali, Ph.D. | (707) 287-4313 | yusuf.ali@ribomic.com | |
Contact: Daniel Pereira, M.D. | (415) 341-4996 | daniel.pereira@ribomic.com |
United States, California | |
Retinal Consultants Medical Group | Recruiting |
Sacramento, California, United States, 95841 | |
Contact: Mia Katz 916-339-2693 katzm@retinalmd.com | |
Principal Investigator: Joel Pearlman, MD, Ph.D. | |
Bay Area Retina Associates | Recruiting |
Walnut Creek, California, United States, 94704 | |
Contact: Sarah Manz 925-943-6800 smanz@bayarearetina.com | |
Principal Investigator: Subhransu Ray, MD | |
United States, Indiana | |
Raj K. Maturi, M.D., P.C. | Recruiting |
Indianapolis, Indiana, United States, 46290 | |
Contact: Vinaya Mahesh 317-805-2198 vinayam@midwesteye.com | |
Principal Investigator: Raj K Maturi, M.D. | |
United States, Texas | |
Valley Retina Institute, PA | Recruiting |
McAllen, Texas, United States, 78503 | |
Contact: Yesina Salinas 956-631-8875 ext 157 ysalinas@vritx.com | |
Principal Investigator: Victor H. Gonzalez, MD | |
Medical Center Ophthalmology Associates | Recruiting |
San Antonio, Texas, United States, 78240 | |
Contact: Muayad Maalah 210-697-2036 ext 2278 muayad@mcoaeyecare.com | |
Principal Investigator: Michael A Singer, MD |
Study Director: | Yusuf Ali, Ph.D. | Ribomic USA |
Responsible Party: | Ribomic USA Inc |
ClinicalTrials.gov Identifier: | NCT04200248 |
Other Study ID Numbers: |
RBM 007-002 |
First Posted: | December 16, 2019 Key Record Dates |
Last Update Posted: | February 17, 2020 |
Last Verified: | February 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Fibrosis Edema Neovascularization |
Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases |