Age-Related Macular DegenerationPhase 2NCT02357342
Sirolimus Versus Anti-Vascular Endothelial Growth Factor (antiVEGF) for Wet AMD
A Phase 2 study testing Sirolimus in people with Age-Related Macular Degeneration, run by Maturi, Raj K., M.D., P.C. at 1 site in United States.
Trial summary
Phase 2 clinical trial, single site, randomized, subject-masked study to determine safety and efficacy of intravitreal injections of Sirolimus in subjects with wet Age-Related Macular Degeneration (wet AMD) with persistent intraretinal or subretinal edema due to neovascular AMD despite previous AntiVEGF treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Age-Related Macular Degeneration
- What is being tested?
- Sirolimus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Jan 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- best corrected visual acuity of 5-65, inclusive, in study eye
- presence of choroid neovascularization secondary to AMD
- persistent edema despite at least 3 previous intravitreal anti-VEGF injections in the past 5 months
Who cannot join
- greater than 100 micron decrease in central subfield thickness on Optical Coherence Topography (OCT) since last standard of care visit
- history of major ophthalmic surgery in the study eye in the past 3 months
- history of significant ocular disease or condition other than exudative AMD that may confound results
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sirolimus Versus AntiVEGF for Wet AMD
Phase 2 clinical trial, single site, randomized, subject-masked study to determine safety and efficacy of intravitreal injections of Sirolimus in subjects with wet Age-Related Macular Degeneration (wet AMD) with persistent intraretinal or subretinal edema due to neovascular AMD despite previous AntiVEGF treatment.
Read the detailed description
Forty subjects will be randomized to receive intravitreal Sirolimus or standard of care treatment in a 1:1 ratio. Over the course of the six month trial plus a 6 month optional extension, subjects will be evaluated monthly. Treatment with Sirolimus will be given at baseline, month 2 and month 4 with sham injections given at months 1, 3 and 5. For subjects in the extension Sirolimus will also be given at months 6, 8 and 10 with sham at month 7, 9, and 11. Subjects in the standard of care group will receive anti-VEGF injections or sham monthly. Retreatment criteria will be based upon continued subretinal edema, intraretinal edema or active chorioretinal neovascularization (CNV)
- Conditions
- Age-Related Macular Degeneration
- Being tested
- Sirolimus, Standard of Care intravitreal injections of anti-VEGF
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SirolimusDrug
Also called DE-109
intravitreal injection
Standard of Care intravitreal injections of anti-VEGFDrug
Also called avastin,bevacizumab, eylea, aflibercept,
intravitreal injections of anti-VEGF
| Study group | Role | What they receive |
|---|---|---|
| Sirolimus | Experimental | Intravitreal Sirolimus Receives: Drug: Sirolimus |
| Standard of Care intravitreal anti-VEGF | Active comparator | anti-VEGF intravitreal injections Receives: Drug: Standard of Care intravitreal injections of anti-VEGF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Edema From Baseline to Month 6 Central Subfield Thickness ) on Heidelberg Optical Coherence Topography
Change in edema from baseline to month 6 as measured by mean difference in microns of central subfield thickness on Heidelberg optical coherence topography in each treatment group
Measured: Baseline to 6 months
Visual Acuity
number of subjects with gain of 0-4 letters of visual acuity
Measured: Baseline to 6 months
Secondary outcomes (1)
Visual Acuity (Best Corrected Visual Acuity)
number of subjects with gain of 5 or more letters of visual acuity
Measured: baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2015 (estimated)
- Study startApr 2015
- Primary completionJan 2017
- Study completionJan 2017
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maturi, Raj K., M.D., P.C.
- Responsible party
- Sponsor
- Investigators
- Raj K Maturi, MD, Principal investigator, Raj K. Maturi, MD, PC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02357342
- Sponsor's protocol ID
- RKM008
- Status last verified
- Jun 2017
- First submitted
- 2 Feb 2015
- Last updated
- 22 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Minturn RJ, Bracha P, Klein MJ, Chhablani J, Harless AM, Maturi RK. Intravitreal sirolimus for persistent, exudative age-related macular degeneration: a Pilot Study. Int J Retina Vitreous. 2021 Feb 16;7(1):11. doi: 10.1186/s40942-021-00281-0.
PubMed 33593448
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sirolimus Versus AntiVEGF for Wet AMD
- ClinicalTrials.gov ID
- NCT02357342
- Acronym / sponsor ID
- RKM008
- Conditions
- Age-Related Macular Degeneration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Maturi, Raj K., M.D., P.C.
- Study start
- Apr 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 6 Feb 2015 (estimated)
- Results
- Posted 5 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 2 clinical trial, single site, randomized, subject-masked study to determine safety and efficacy of intravitreal injections of Sirolimus in subjects with wet Age-Related Macular Degeneration (wet AMD) with persistent intraretinal or subretinal edema due to neovascular AMD despite previous AntiVEGF treatment.
Detailed description
Forty subjects will be randomized to receive intravitreal Sirolimus or standard of care treatment in a 1:1 ratio. Over the course of the six month trial plus a 6 month optional extension, subjects will be evaluated monthly. Treatment with Sirolimus will be given at baseline, month 2 and month 4 with sham injections given at months 1, 3 and 5. For subjects in the extension Sirolimus will also be given at months 6, 8 and 10 with sham at month 7, 9, and 11. Subjects in the standard of care group will receive anti-VEGF injections or sham monthly. Retreatment criteria will be based upon continued subretinal edema, intraretinal edema or active chorioretinal neovascularization (CNV)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sirolimus | Experimental | Drug: SirolimusIntravitreal Sirolimus |
| Standard of Care intravitreal anti-VEGF | Active comparator | Drug: Standard of Care intravitreal injections of anti-VEGFanti-VEGF intravitreal injections |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- best corrected visual acuity of 5-65, inclusive, in study eye
- presence of choroid neovascularization secondary to AMD
- persistent edema despite at least 3 previous intravitreal anti-VEGF injections in the past 5 months
Key exclusion criteria (3 listed)
- greater than 100 micron decrease in central subfield thickness on Optical Coherence Topography (OCT) since last standard of care visit
- history of major ophthalmic surgery in the study eye in the past 3 months
- history of significant ocular disease or condition other than exudative AMD that may confound results
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 |
|---|---|---|
| SirolimusAlso: DE-109intravitreal injection | Drug | Sirolimus |
| Standard of Care intravitreal injections of anti-VEGFAlso: avastin,bevacizumab, eylea, aflibercept,intravitreal injections of anti-VEGF | Drug | Standard of Care intravitreal anti-VEGF |
Primary outcome
Change in Edema From Baseline to Month 6 Central Subfield Thickness ) on Heidelberg Optical Coherence Topography
Time frame: Baseline to 6 months
Change in edema from baseline to month 6 as measured by mean difference in microns of central subfield thickness on Heidelberg optical coherence topography in each treatment group
Visual Acuity
Time frame: Baseline to 6 months
number of subjects with gain of 0-4 letters of visual acuity
1 secondary outcome
Visual Acuity (Best Corrected Visual Acuity)
Time frame: baseline to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33593448Minturn RJ, Bracha P, Klein MJ, Chhablani J, Harless AM, Maturi RK. Intravitreal sirolimus for persistent, exudative age-related macular degeneration: a Pilot Study. Int J Retina Vitreous. 2021 Feb 16;7(1):11. doi: 10.1186/s40942-021-00281-0.
- 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, MD principal investigator
Raj K. Maturi, MD, PC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sirolimus 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 3 inclusion and 3 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 22 Jun 2017. 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 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 5 Jun 2017). 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?
Change in Edema From Baseline to Month 6 Central Subfield Thickness ) on Heidelberg Optical Coherence Topography (time frame: Baseline to 6 months). 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?
On the ClinicalTrials.gov record for NCT02357342, which also lists 1 linked publication.
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 22 Jun 2017.