Exudative Age-related Macular DegenerationPhase 2RAMENNCT04640272
A Multi-Center, Open Label, Extension Study Assessing the Efficacy and Safety of Additional Intravitreal Injections of RBM-007 in Subjects With Wet Age-related Macular Degeneration
A Phase 2 study testing RBM-007 in people with Exudative Age-related Macular Degeneration, run by Ribomic USA Inc at 6 sites in United States.
Trial summary
This is a multi-center, open label, extension study of NCT04200248 assessing the efficacy and safety of additional intravitreal injections of RBM-007 in subjects with wet age-related macular degeneration. 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 6 sitesUnited States
- Study dates
- 3 Nov 2020to 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 on the Institutional Review Board (IRB)/Ethics Committee (EC) approved Informed Consent Form (ICF) and provide authorization as appropriate for local privacy regulations.
- Male or female 55 years of age or older on the date of signing the ICF and able and willing to comply with all treatment and study procedures.
- Subjects must have completed all scheduled visits of previous study. Subjects can only enter this study after exiting previous study
- Subjects for which previous previous masked treatment arms with intravitreal anti-vascular endothelial growth factor (anti-VEGF) agents Eylea® and/or RBM-007 has not demonstrated improvement in vision; subjects with less than 15 letter Best Corrected Visual Acuity (BCVA) improvement in TOFU study at exit visit over its baseline.
- Diagnosis of exudative age-related macular degeneration (AMD) in the study eye, as assessed by spectral domain optical coherence tomography (SD-OCT).
- Absence of central atrophy or retinal epithelial tear in the fovea or any condition preventing VA improvement in the study eye.
- BCVA of 24 ETDRS letters (20/320) or better in the fellow eye.
- Reasonably clear media and some fixation in the study eye to allow for good quality SD-OCT and fundus photography.
Who cannot join
- 1. Subjects whose vision have improved >15 BCVA letters at exit visit of previous study over its baseline 2. Subjects who experienced any drug related serious adverse event during previous study
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Raj K. Maturi, M.D., P.C.
Indianapolis, Indiana, 46290
Valley Retina Institute
McAllen, Texas, 78503
Retinal Research Institute, LLC
Phoenix, Arizona, 85053
Retinal Medical Consultants 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, Open Label, TOFU Extension Study Assessing the Efficacy and Safety of Additional Intravitreal Injections of RBM-007 in Subjects With Wet Age-related Macular Degeneration
This is a multi-center, open label, extension study of NCT04200248 assessing the efficacy and safety of additional intravitreal injections of RBM-007 in subjects with wet age-related macular degeneration.
- Being tested
- RBM-007
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RBM-007Drug
Intravitreal injection
| Study group | Role | What they receive |
|---|---|---|
| RBM-007 injectable solution | Experimental | intravitreal injection Receives: Drug: RBM-007 |
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
Measured: Month 4
Secondary outcomes (2)
Visual Acuity - Categorical
Percentage of patients gaining more than 15 letters as measured by Best Corrected Visual Acuity from Baseline
Measured: Month 4
Change From Baseline in Central Macular Subfield Thickness
Measured: Month 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start3 Nov 2020
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label, non-comparative
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ribomic USA Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Padma Bezwada, PhD, Study director, Ribomic USA Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04640272
- Sponsor's protocol ID
- RBM 007-003
- Acronym
- RAMEN
- Status last verified
- May 2023
- First submitted
- 17 Nov 2020
- 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, Open Label, TOFU Extension Study Assessing the Efficacy and Safety of Additional Intravitreal Injections of RBM-007 in Subjects With Wet Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT04640272
- Acronym / sponsor ID
- RAMEN / RBM 007-003
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ribomic USA IncIndustry (pharma, biotech, devices)
- Study start
- 3 Nov 2020 (actual)
- Primary completion
- 19 Nov 2021 (actual)
- Study completion
- 22 Dec 2021 (actual)
- First posted
- 23 Nov 2020 (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 multi-center, open label, extension study of NCT04200248 assessing the efficacy and safety of additional intravitreal injections of RBM-007 in subjects with wet age-related macular degeneration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label, non-comparative
| Arm | Type | Receives |
|---|---|---|
| RBM-007 injectable solution | Experimental | Drug: RBM-007intravitreal 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 on the Institutional Review Board (IRB)/Ethics Committee (EC) approved Informed Consent Form (ICF) and provide authorization as appropriate for local privacy regulations.
- Male or female 55 years of age or older on the date of signing the ICF and able and willing to comply with all treatment and study procedures.
- Subjects must have completed all scheduled visits of previous study. Subjects can only enter this study after exiting previous study
- Subjects for which previous previous masked treatment arms with intravitreal anti-vascular endothelial growth factor (anti-VEGF) agents Eylea® and/or RBM-007 has not demonstrated improvement in vision; subjects with less than 15 letter Best Corrected Visual Acuity (BCVA) improvement in TOFU study at exit visit over its baseline.
- Diagnosis of exudative age-related macular degeneration (AMD) in the study eye, as assessed by spectral domain optical coherence tomography (SD-OCT).
Key exclusion criteria (1 listed)
- 1. Subjects whose vision have improved >15 BCVA letters at exit visit of previous study over its baseline 2. Subjects who experienced any drug related serious adverse event during previous study
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-007Intravitreal injection | Drug | RBM-007 injectable solution |
Primary outcome
Visual Acuity - Continuous
Time frame: Month 4
Mean change in Best Corrected Visual Acuity from Baseline
2 secondary outcomes
Visual Acuity - Categorical
Time frame: Month 4
Change From Baseline in Central Macular Subfield Thickness
Time frame: Month 4
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
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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, PhD study director
Ribomic USA Inc
6 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 in people with Exudative Age-related Macular Degeneration, run by Ribomic USA Inc at 6 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 1 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 6 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: Month 4). 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.