Age-related Macular DegenerationPhase 1/2SUSHINCT03633084
RBM-007 in Subjects witH ExudatIve Age-related Macular Degeneration
A Phase 1/2 study testing RBM-007 Injectable Solution in people with Age-related Macular Degeneration, run by Ribomic USA Inc at 4 sites in United States.
Trial summary
This is an open label, non-controlled, dose-escalating study assessing the safety, tolerability, and bioactivity of a single intravitreal (i.vt.) injection of RBM-007 in approximately nine subjects with exudative age-related macular degeneration. Read more about this study
- Who is it for?
- Ages 55 to 99 years
- Conditions the study is for
- Age-related Macular Degeneration
- What is being tested?
- RBM-007 Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 4 sitesUnited States
- Study dates
- 29 Aug 2018to 26 Jun 2019
- Phase
- Phase 1/2
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female 55 years of age or older on the date of signing the informed consent form and able and willing to comply with all treatment and follow-up study procedures.
- At Screening Visit, subjects must meet all the following inclusion criteria:
- Must have had prior treatment in the study eye with any intravitreal vasoactive endothelial growth factor (VEGF) medication (at least 3 anti-VEGF) treatments within the prior 2-6 months), throughout which clinical examination and SD-OCT imaging has shown recurrent or persistent exudative activity, as shown by the presence of intraretinal or subretinal fluid, and/or subretinal exudation or hemorrhage.
- Best corrected visual acuity of 65 to 20 Early Treatment of Diabetic Retinopathy Study (ETDRS) letters (20/50 to 20/400) in the study eye.
- Presence of significant subretinal fluid and/or cystoid macular edema secondary to exudative age-related macular degeneration as assessed by optical coherence tomography in the study eye, with a minimum of 300 µm within the central subfield.
- Total lesion size of ≤9 disc areas, lesion containing ≤50% hemorrhage and ≤50% subretinal fibrosis and ≤50% retinal pigment epithelial atrophy in the study eye.
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- Reasonably clear media and reasonable fixation ability in the study eye to allow for good quality tomography and fundus photography.
- At Baseline Visit (Day 0), subjects must meet all the following inclusion criteria:
- Best Corrected Visual Acuity (BCVA) of 65 to 20 ETDRS letters (20/50 to 20/400) in the study eye.
- Presence of significant subretinal and/or intraretinal fluid secondary to exudative age-related macular degeneration as assessed by SD-OCT in the study eye, with a minimum of 300 µm within the central subfield.
- Total lesion size of ≤9 disc areas, containing ≤ 50% hemorrhage and ≤ 50% fibrosis and ≤ 50% retinal pigment epithelial atrophy in the study eye.
Who cannot join
- Ocular exclusion criteria:
- BCVA better than 65 ETDRS letters (20/50) in the study eye.
- BCVA worse than 20 ETDRS letters (20/400) in study eye.
- Fellow eye BCVA worse than 35 ETDRS letters (20/200).
- Use of any of the following treatments to the study eye:
- Intravitreal anti-VEGF injection (ranibizumab, aflibercept or bevacizumab) in the study eye within the past 4 weeks or less prior to Baseline Visit and RBM-007 injection.
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- Intravitreal or periocular corticosteroid, within 3 months prior to Baseline Visit (Day 0) and throughout the study;
- Fluocinolone acetonide intravitreal implant, within 12 months prior to Baseline Visit (Day 0) and throughout the study;
- Visudyne® (verteporfin) photodynamic therapy, within 3 months prior to Baseline Visit (Day 0) and throughout the study.
- Uncontrolled or advanced glaucoma, defined by an intraocular pressure (IOP) of >21 mmHg or cup/disc ratio > 0.8 while on medical therapy, or chronic ocular hypotony (<6 mmHg) in the study eye.
- Evidence of ocular disease other than exudative AMD in the study eye that may confound the outcome of the study (e.g., active diabetic retinopathy, posterior uveitis, adult vitelliform dystrophy, moderate/severe myopic degeneration).
- History of vitrectomy surgery in the study eye.
- Anticipated need for any ocular surgery involving the study eye during the course of the study.
- Nd:YAG laser capsulotomy within 28 days prior to Baseline Visit (Day 0) in the study eye.
- Intraocular surgery, including lens removal or ophthalmologic laser procedure, within 90 days prior to Baseline Visit (Day 0) in the study eye.
- Ocular or periocular infection in either eye.
- Pupillary dilation inadequate for good quality fundus photography in the study eye.
- Media opacity that would limit clinical visualization, fundus photography, fluorescein angiography, or SD-OCT evaluation in the study eye.
- History of herpetic ophthalmic infection in the study eye or adnexa.
- Presence of known toxoplasmosis or toxoplasmosis scar in either eye.
- Presence or history of any form of ocular malignancy including choroidal melanoma in the study eye.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Retinal Consultants Medical Group
Sacramento, California, 95819
Retinal Consultants Medical Group
Sacramento, California, 95841
Stanford University
Stanford, California, 94303
Bay Area Retina Associates
Walnut Creek, California, 94704
About this study
Official title: Phase 1/2 Open Label, Dose-escalation Study of the Safety and OcUlar Tolerability of a Single Intravitreal Injection of RBM-007 in Subjects witH ExudatIve Age-related Macular Degeneration (SUSHI)
This is an open label, non-controlled, dose-escalating study assessing the safety, tolerability, and bioactivity of a single intravitreal (i.vt.) injection of RBM-007 in approximately nine subjects with exudative age-related macular degeneration.
Read the detailed description
Nine subjects in three dose cohorts (3 subjects each cohort) will receive a single i.vt. injection of RBM-007 in the study eye. Subjects will be followed through Day 56.
- Conditions
- Age-related Macular Degeneration
- Being tested
- RBM-007 Injectable Solution
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RBM-007 Injectable SolutionDrug
(No additional description)
| Study group | Role | What they receive |
|---|---|---|
| RBM-007 Injectable Solution - 0.2 mg | Experimental | No additional information. Receives: Drug: RBM-007 Injectable Solution |
| RBM-007 Injectable Solution - 1.0 mg | Experimental | No additional information. Receives: Drug: RBM-007 Injectable Solution |
| RBM-007 Injectable Solution - 2.0 mg | Experimental | No additional information. Receives: Drug: RBM-007 Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Safety as Assessed Using Biomicroscopy to Investigate Ocular Tolerability
Biomicroscopy is used by an ophthalmologist to assess the health of the front of the eye. The measure is the number of subjects with abnormal findings that were not present at screening.
Measured: Day 56
Ocular Safety as Assessed Using Ophthalmoscopy to Investigate Ocular Tolerability
Ophthalmoscopy is used by an ophthalmologist to assess the health of the back of the eye. The measure is the number of subjects with abnormal findings that were not present at screening.
Measured: Day 56
Secondary outcomes (1)
Ocular Tolerability as Assessed by Number and Nature of Adverse Events
Adverse events (ocular or non-ocular)
Measured: Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start29 Aug 2018
- Primary completion26 Jun 2019
- Study completion26 Jun 2019
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 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- This is an open label, non-controlled, sequential, dose-escalating study
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ribomic USA Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yusuf Ali, Ph.D., Study director, Ribomic USA Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03633084
- Sponsor's protocol ID
- RBM-007-001
- Acronym
- SUSHI
- Status last verified
- Dec 2020
- First submitted
- 18 Jul 2018
- Last updated
- 5 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2 Open Label, Dose-escalation Study of the Safety and OcUlar Tolerability of a Single Intravitreal Injection of RBM-007 in Subjects witH ExudatIve Age-related Macular Degeneration (SUSHI)
- ClinicalTrials.gov ID
- NCT03633084
- Acronym / sponsor ID
- SUSHI / RBM-007-001
- Conditions
- Age-related Macular Degeneration
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Ribomic USA IncIndustry (pharma, biotech, devices)
- Study start
- 29 Aug 2018 (actual)
- Primary completion
- 26 Jun 2019 (actual)
- Study completion
- 26 Jun 2019 (actual)
- First posted
- 16 Aug 2018 (actual)
- Results
- Posted 5 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open label, non-controlled, dose-escalating study assessing the safety, tolerability, and bioactivity of a single intravitreal (i.vt.) injection of RBM-007 in approximately nine subjects with exudative age-related macular degeneration.
Detailed description
Nine subjects in three dose cohorts (3 subjects each cohort) will receive a single i.vt. injection of RBM-007 in the study eye. Subjects will be followed through Day 56.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is an open label, non-controlled, sequential, dose-escalating study
| Arm | Type | Receives |
|---|---|---|
| RBM-007 Injectable Solution - 0.2 mg | Experimental | Drug: RBM-007 Injectable SolutionNo additional information. |
| RBM-007 Injectable Solution - 1.0 mg | Experimental | Drug: RBM-007 Injectable SolutionNo additional information. |
| RBM-007 Injectable Solution - 2.0 mg | Experimental | Drug: RBM-007 Injectable SolutionNo additional information. |
Who may qualify
- Ages
- 55 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female 55 years of age or older on the date of signing the informed consent form and able and willing to comply with all treatment and follow-up study procedures.
- At Screening Visit, subjects must meet all the following inclusion criteria:
- Must have had prior treatment in the study eye with any intravitreal vasoactive endothelial growth factor (VEGF) medication (at least 3 anti-VEGF) treatments within the prior 2-6 months), throughout which clinical examination and SD-OCT imaging has shown recurrent or persistent exudative activity, as shown by the presence of intraretinal or subretinal fluid, and/or subretinal exudation or hemorrhage.
- Best corrected visual acuity of 65 to 20 Early Treatment of Diabetic Retinopathy Study (ETDRS) letters (20/50 to 20/400) in the study eye.
- Presence of significant subretinal fluid and/or cystoid macular edema secondary to exudative age-related macular degeneration as assessed by optical coherence tomography in the study eye, with a minimum of 300 µm within the central subfield.
Key exclusion criteria (21 listed)
- BCVA better than 65 ETDRS letters (20/50) in the study eye.
- BCVA worse than 20 ETDRS letters (20/400) in study eye.
- Fellow eye BCVA worse than 35 ETDRS letters (20/200).
- Intravitreal anti-VEGF injection (ranibizumab, aflibercept or bevacizumab) in the study eye within the past 4 weeks or less prior to Baseline Visit and RBM-007 injection.
- Intravitreal or periocular corticosteroid, within 3 months prior to Baseline Visit (Day 0) and throughout the 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-007 Injectable Solution(No additional description) | Drug | RBM-007 Injectable Solution - 0.2 mg, RBM-007 Injectable Solution - 1.0 mg, RBM-007 Injectable Solution - 2.0 mg |
Primary outcome
Ocular Safety as Assessed Using Biomicroscopy to Investigate Ocular Tolerability
Time frame: Day 56
Biomicroscopy is used by an ophthalmologist to assess the health of the front of the eye. The measure is the number of subjects with abnormal findings that were not present at screening.
Ocular Safety as Assessed Using Ophthalmoscopy to Investigate Ocular Tolerability
Time frame: Day 56
Ophthalmoscopy is used by an ophthalmologist to assess the health of the back of the eye. The measure is the number of subjects with abnormal findings that were not present at screening.
1 secondary outcome
Ocular Tolerability as Assessed by Number and Nature of Adverse Events
Time frame: Day 56
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Yusuf Ali, Ph.D. study director
Ribomic USA Inc
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing RBM-007 Injectable Solution in people with Age-related Macular Degeneration, run by Ribomic USA Inc at 4 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 11 inclusion and 21 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 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 5 Jan 2021). 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?
Ocular Safety as Assessed Using Biomicroscopy to Investigate Ocular Tolerability (time frame: Day 56). The study lists 2 primary outcomes in all. 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 5 Jan 2021.