Age Related Macular DegenerationPhase 1/2TEMPURANCT04895293
RBM-007 in Treatment naïve Exudative Age-related Macular Degeneration
A Phase 1/2 study testing RBM-007 Injectable Solution in people with Age Related Macular Degeneration, run by Maturi, Raj K., M.D., P.C. at 1 site in United States.
Trial summary
This study is a single-center, open label, 4-month study, designed to evaluate the safety and treatment efficacy of RBM-007 in patients with intraretinal or subretinal edema due to previously untreated neovascular AMD. Up to 5 subjects will be randomized to receive study medication. Read more about this study
- Who is it for?
- Ages 50 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
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2021to 4 Mar 2022
- 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 50 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- General Inclusion Criteria:
- Male or female patients, 50 years of age or older at baseline
- Patient has completed/signed an informed consent prior to any study-related procedures and is able to follow study instructions and likely to complete all required visits.
- Ocular Inclusion Criteria:
- Best Corrected Visual Acuity (BCVA) 5 - 73 ETDRS letters (20/800-20/40 Snellen equivalent), inclusive, in study eye
- Presence of choroidal neovascularization secondary to AMD
- Clear ocular media and adequate pupil dilation to permit good quality photographic imaging.
Who cannot join
- General Exclusion Criteria:
- Females who are pregnant, nursing, planning a pregnancy or who are of childbearing potential not using a reliable method of contraception.
- History or current evidence of hypersensitivity to any components of the study medication or fluorescein, as assessed by the investigator.
- Participation in any investigational drug or device study within 30 days prior to baseline
- History or current evidence of a medical condition that may, in the opinion of the investigator, preclude the safe administration of study medication or affect the results of the study.
- Ocular Exclusion Criteria:
Show all 12Show fewer
- Active ocular or periocular infections, malignancy
- Aphakia
- History of pars plana vitrectomy in the study eye
- History of major ophthalmic surgery in the past 3 months in the study eye, or minor surgery in the past 30 days
- History of significant ocular disease other than exudative AMD that may confound results
- Uncontrolled glaucoma (defined as intraocular pressure >21mm Hg despite treatment with ocular hypotensive medications at baseline).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of RBM-007 in Subjects With Treatment naïve Exudative Age-related Macular Degeneration (AMD)
This study is a single-center, open label, 4-month study, designed to evaluate the safety and treatment efficacy of RBM-007 in patients with intraretinal or subretinal edema due to previously untreated neovascular AMD. Up to 5 subjects will be randomized to receive study medication. Study treatment will be administered by intravitreal injections.
- 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
Sterile solution
| Study group | Role | What they receive |
|---|---|---|
| RBM-007 Injectable Solution - 2.0 mg | Experimental | Single intravitreal injection in study eye Receives: Drug: RBM-007 Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macular Edema
Central subfield thickness on optical coherence tomography
Measured: 3 months
Secondary outcomes (1)
Visual Acuity
Change from Baseline in Best Corrected Visual Acuity
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start15 Jun 2021
- Primary completion8 Feb 2022
- Study completion4 Mar 2022
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
- Not applicable
- Intervention model
- Single group
- Model description
- All subjects receive the study treatment
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maturi, Raj K., M.D., P.C.
- Responsible party
- Sponsor
- Investigators
- Raj K. Maturi, M.D., Study chair, Midwest Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04895293
- Sponsor's protocol ID
- RKM-011
- Acronym
- TEMPURA
- Status last verified
- Mar 2023
- First submitted
- 17 May 2021
- Last updated
- 12 Apr 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 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of RBM-007 in Subjects With Treatment naïve Exudative Age-related Macular Degeneration (AMD)
- ClinicalTrials.gov ID
- NCT04895293
- Acronym / sponsor ID
- TEMPURA / RKM-011
- Conditions
- Age Related Macular Degeneration
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Maturi, Raj K., M.D., P.C.
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 8 Feb 2022 (actual)
- Study completion
- 4 Mar 2022 (actual)
- First posted
- 20 May 2021 (actual)
- Results
- Posted 12 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a single-center, open label, 4-month study, designed to evaluate the safety and treatment efficacy of RBM-007 in patients with intraretinal or subretinal edema due to previously untreated neovascular AMD. Up to 5 subjects will be randomized to receive study medication. Study treatment will be administered by intravitreal injections.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All subjects receive the study treatment
| Arm | Type | Receives |
|---|---|---|
| RBM-007 Injectable Solution - 2.0 mg | Experimental | Drug: RBM-007 Injectable SolutionSingle intravitreal injection in study eye |
Who may qualify
- Ages
- 50 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- General Inclusion Criteria:
- Male or female patients, 50 years of age or older at baseline
- Patient has completed/signed an informed consent prior to any study-related procedures and is able to follow study instructions and likely to complete all required visits.
- Best Corrected Visual Acuity (BCVA) 5 - 73 ETDRS letters (20/800-20/40 Snellen equivalent), inclusive, in study eye
- Presence of choroidal neovascularization secondary to AMD
Key exclusion criteria (12 listed)
- General Exclusion Criteria:
- Females who are pregnant, nursing, planning a pregnancy or who are of childbearing potential not using a reliable method of contraception.
- History or current evidence of hypersensitivity to any components of the study medication or fluorescein, as assessed by the investigator.
- Participation in any investigational drug or device study within 30 days prior to baseline
- History or current evidence of a medical condition that may, in the opinion of the investigator, preclude the safe administration of study medication or affect the results of 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 SolutionSterile solution | Drug | RBM-007 Injectable Solution - 2.0 mg |
Primary outcome
Macular Edema
Time frame: 3 months
Central subfield thickness on optical coherence tomography
1 secondary outcome
Visual Acuity
Time frame: 3 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 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.
Raj K. Maturi, M.D. study chair
Midwest Eye Institute
1 site 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 Maturi, Raj K., M.D., P.C. at 1 site 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 7 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 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 12 Apr 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?
Macular Edema (time frame: 3 months). 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 12 Apr 2023.