Exudative Age-related Macular DegenerationPhase 2TOFUNCT04200248
A Phase II Study of RBM-007 Alone and RBM-007 With Eylea® in Subjects With Wet Age-related Macular Degeneration
A Phase 2 study testing RBM-007 Injectable Solution and Aflibercept in people with Exudative Age-related Macular Degeneration, run by Ribomic USA Inc at 8 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Exudative Age-related Macular Degeneration
- What is being tested?
- RBM-007 Injectable Solution and Aflibercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 8 sitesUnited States
- Study dates
- 2 Dec 2019to 22 Dec 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Ocular:
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Advanced Research, LLC
Coral Springs, Florida, 33067
Raj K. Maturi, M.D., P.C.
Indianapolis, Indiana, 46290
Georgia Retina, P.C.
Marietta, Georgia, 30060
Valley Retina Institute, PA
McAllen, Texas, 78503
Retinal Research Institute, LLC
Phoenix, Arizona, 85053
Retinal Consultants Medical Group
Sacramento, California, 95841
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240
Bay Area Retina Associates
Walnut Creek, California, 94704
About this study
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
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).
Read the detailed description
RBM-007 is a novel oligonucleotide-based aptamer having potent anti-FGF2 activity and anti-VEGF-expression activity
- Being tested
- RBM-007 Injectable Solution, Aflibercept, Sham
- Keywords
- Fibrosis, Edema, Neovascularization
- Medical subject headings
- Fibrosis, Edema, Neovascularization, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RBM-007 Injectable SolutionDrug
RBM-007 Injectable Solution
AfliberceptDrug
EYLEA® (aflibercept) Injection, for Intravitreal Use
ShamDrug
Sham intravitreal injection
| Study group | Role | What they receive |
|---|---|---|
| Sham + RBM-007 | Experimental | Sham + RBM-007 intravitreal injection Receives: Drug: RBM-007 Injectable Solution; Drug: Sham |
| RBM-007 + Aflibercept | Experimental | RBM-007 + Aflibercept intravitreal injection Receives: Drug: RBM-007 Injectable Solution; Drug: Aflibercept |
| Sham + Aflibercept | Active comparator | Sham + Aflibercept intravitreal injection Receives: Drug: Aflibercept; Drug: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity - Continuous
Mean change in Best Corrected Visual Acuity from Baseline to Week 16
Measured: Week 16
Secondary outcomes (5)
Visual Acuity - Categorical
Percentage of patients gaining >= 15 letters as measured by Best Corrected Visual Acuity from Baseline at Week 16
Measured: Week 16
Macular Thickness Change
Change from Baseline in Central Subfield Thickness by spectral domain optical coherence tomography at Week 16
Measured: Week 16
Macular Volume Change
Change from Baseline in macular volume by spectral domain optical coherence tomography at Week 16
Measured: Week 16
Fibrosis Change
Change from Baseline in sub-retinal hyper-reflective material by spectral domain optical coherence tomography at Week 16
Measured: Week 16
Safety - Ocular
Ocular examination (biomicroscopy and ophthalmoscopy) at Week 20 - Number of participants with additional corneal abnormalities
Measured: Week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start2 Dec 2019
- Primary completion19 Nov 2021
- Study completion22 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Exudative Age-related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ribomic USA Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Padma Bezwada, Ph.D., Study director, RIBOMIC USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04200248
- Sponsor's protocol ID
- RBM 007-002
- Acronym
- TOFU
- Status last verified
- Apr 2023
- First submitted
- 8 Dec 2019
- Last updated
- 8 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04200248
- Acronym / sponsor ID
- TOFU / RBM 007-002
- Keywords
- Fibrosis, Edema, Neovascularization
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Ribomic USA IncIndustry (pharma, biotech, devices)
- Study start
- 2 Dec 2019 (actual)
- Primary completion
- 19 Nov 2021 (actual)
- Study completion
- 22 Dec 2021 (actual)
- First posted
- 16 Dec 2019 (actual)
- Results
- Posted 8 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sham + RBM-007 | Experimental | Drug: RBM-007 Injectable Solution, Drug: ShamSham + RBM-007 intravitreal injection |
| RBM-007 + Aflibercept | Experimental | Drug: RBM-007 Injectable Solution, Drug: AfliberceptRBM-007 + Aflibercept intravitreal injection |
| Sham + Aflibercept | Active comparator | Drug: Aflibercept, Drug: ShamSham + Aflibercept intravitreal injection |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (12 listed)
- Ocular:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RBM-007 Injectable SolutionRBM-007 Injectable Solution | Drug | RBM-007 + Aflibercept, Sham + RBM-007 |
| AfliberceptEYLEA® (aflibercept) Injection, for Intravitreal Use | Drug | RBM-007 + Aflibercept, Sham + Aflibercept |
| ShamSham intravitreal injection | Drug | Sham + Aflibercept, Sham + RBM-007 |
Primary outcome
Visual Acuity - Continuous
Time frame: Week 16
Mean change in Best Corrected Visual Acuity from Baseline to Week 16
5 secondary outcomes
Visual Acuity - Categorical
Time frame: Week 16
Macular Thickness Change
Time frame: Week 16
Macular Volume Change
Time frame: Week 16
Fibrosis Change
Time frame: Week 16
Safety - Ocular
Time frame: Week 20
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Exudative Age-related Macular Degeneration
RecruitingPhase 3
A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD
Neovascular Age-related Macular Degeneration
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 1/2
Phase 1/2 Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration
Age-Related Macular Degeneration, Geographic Atrophy
Not yet recruitingPhase 2
A Study to Evaluate the Efficacy and Safety of VIS-101 in Participants With Neovascular Age-Related Macular Degeneration
Neovascular Age Related Macular Degeneration(nAMD)
RecruitingPhase 2
Safety and Efficacy of AIV007 Periocular Injection in Patients With Neovascular Age-Related Macular Degeneration
Neovascular (Wet) Age-Related Macular Degeneration
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Padma Bezwada, Ph.D. study director
RIBOMIC USA
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RBM-007 Injectable Solution and Aflibercept in people with Exudative Age-related Macular Degeneration, run by Ribomic USA Inc at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Acuity - Continuous (time frame: Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2023.