Exudative Age Related Macular DegenerationPhase 2NCT02732899
Sirolimus in Conjunction With Eylea vs Eylea Alone for Exudative AMD
A Phase 2 study testing Sirolimus and EYLEA in people with Exudative Age Related Macular Degeneration, run by Maturi, Raj K., M.D., P.C. at 1 site in United States.
Trial summary
To determine safety and efficacy of intravitreal injections of Sirolimus with adjunct EYLEA in subjects with exudative age related macular degeneration (AMD) with persistent intraretinal or subretinal edema due to neovascular AMD despite previous intravitreal anti-vascular endothelial growth factor (antiVEGF)… Read more about this study
- Who is it for?
- Ages 50 to 99 years
- Conditions the study is for
- Exudative Age Related Macular Degeneration
- What is being tested?
- Sirolimus and EYLEA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to 4 Apr 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 50 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 (Study eye only):
- BCVA 5 - 75 (20/800-20/30), inclusive, in study eye; if both eyes are eligible, the eye with the best potential visual improvement as determined by the investigator will be selected for treatment.
- Presence of choroidal neovascularization secondary to AMD
- At least 3 previous intravitreal anti-VEGF injections in the past 6 months
- Injection of antiVEGF may be deferred for at least 4 weeks from randomization based on clinical assessment of AMD by the investigator.
- Clear ocular media and adequate pupil dilation to permit good quality photographic imaging -
Who cannot join
- 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 (Study eye only):
- Decrease of greater than 150 microns in central subfield thickness as measured by OCT since the last intravitreal injection in the study eye
Show all 15Show fewer
- Aphakia
- History of pars plana vitrectomy in the study eye
- History of major ophthalmic surgery in the study eye in the past 3 months and any ophthalmic surgery in the study eye within the past 30 days
- History of significant ocular disease or condition other than exudative AMD that may confound results
- Uncontrolled glaucoma (defined as intraocular pressure >21mm Hg despite treatment with two or more ocular hypotensive medications at baseline)
- No active ocular or periocular infections, or ocular malignancy including lymphoma
- Presence of significant epiretinal membrane
- Significant vitreoretinal traction
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sirolimus in Conjunction With EYLEA® (Aflibercept) Versus EYLEA® Alone for Exudative AMD
To determine safety and efficacy of intravitreal injections of Sirolimus with adjunct EYLEA in subjects with exudative age related macular degeneration (AMD) with persistent intraretinal or subretinal edema due to neovascular AMD despite previous intravitreal anti-vascular endothelial growth factor (antiVEGF) treatment.
Read the detailed description
This study is a single-center, masked, randomized, 36 week study, designed to evaluate the safety and treatment efficacy of intravitreal Sirolimus with adjunct EYLEA® (aflibercept) in patients with persistent edema due to neovascular AMD versus EYLEA® (aflibercept) alone. Twenty (20) patients will be randomized to receive study medication in a 1:1 ratio. Study treatment will be administered by intravitreal injections. The sham injections given in the EYLEA® alone group are needleless and they are given in order to help preserve the masking of those subjects in that treatment group.
- Being tested
- Sirolimus, EYLEA
- Keywords
- AMD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SirolimusDrug
Also called DE-109
EYLEADrug
Also called aflibercept
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Sirolimus 440ug for intravitreal injection will be provided in sterile single-use glass vials. One single-dose vial will be packaged in a box for each patient injection. Sirolimus injections will be given at baseline, week 4, 12, 20 and 28. EYLEA® (aflibercept) intravitreal injections will be given at week 1, 8, 16, 24 and 32. Receives: Drug: Sirolimus; Drug: EYLEA |
| Group 2 | Active comparator | Intravitreal injection of EYLEA® (aflibercept) will be given at baseline, week 8, 16, 24 and 32. Sham injections will be given at week 1, 4, 12, 20, and 28 in order to maintain masking of patient to treatment assignment Receives: Drug: EYLEA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Central Subfield Thickness on OCT From Baseline to Week 36
the amount of change in intraretinal and subretinal fluid as measured by microns of central subfield thickness (CST) on Heidelberg Optical Coherence Tomography (OCT)
Measured: baseline to week 36
Secondary outcomes (1)
Change in Best Corrected Visual Acuity (BCVA) From Baseline to Week 36
Measured: baseline to week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2016 (estimated)
- Study startApr 2016
- Primary completion20 Mar 2017
- Study completion4 Apr 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 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 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
- NCT02732899
- Sponsor's protocol ID
- RKM009
- Status last verified
- Jan 2018
- First submitted
- 5 Apr 2016
- Last updated
- 14 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Rowe LW, Minturn RJ, Burgett LA, Bracha P, Maturi RK. Intravitreal sirolimus with adjunct aflibercept versus aflibercept monotherapy for persistent, exudative age-related macular degeneration: a pilot study. Int J Retina Vitreous. 2023 Jan 5;9(1):1. doi: 10.1186/s40942-022-00437-6.
PubMed 36604756
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sirolimus in Conjunction With EYLEA® (Aflibercept) Versus EYLEA® Alone for Exudative AMD
- ClinicalTrials.gov ID
- NCT02732899
- Acronym / sponsor ID
- RKM009
- Keywords
- AMD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Maturi, Raj K., M.D., P.C.
- Study start
- Apr 2016
- Primary completion
- 20 Mar 2017 (actual)
- Study completion
- 4 Apr 2017 (actual)
- First posted
- 11 Apr 2016 (estimated)
- Results
- Posted 14 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine safety and efficacy of intravitreal injections of Sirolimus with adjunct EYLEA in subjects with exudative age related macular degeneration (AMD) with persistent intraretinal or subretinal edema due to neovascular AMD despite previous intravitreal anti-vascular endothelial growth factor (antiVEGF) treatment.
Detailed description
This study is a single-center, masked, randomized, 36 week study, designed to evaluate the safety and treatment efficacy of intravitreal Sirolimus with adjunct EYLEA® (aflibercept) in patients with persistent edema due to neovascular AMD versus EYLEA® (aflibercept) alone. Twenty (20) patients will be randomized to receive study medication in a 1:1 ratio. Study treatment will be administered by intravitreal injections. The sham injections given in the EYLEA® alone group are needleless and they are given in order to help preserve the masking of those subjects in that treatment group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Sirolimus, Drug: EYLEASirolimus 440ug for intravitreal injection will be provided in sterile single-use glass vials. One single-dose vial will be packaged in a box for each patient injection. Sirolimus injections will be given at baseline, week 4, 12, 20 and 28. EYLEA® (aflibercept) intravitreal injections will be given at week 1, 8, 16, 24 and 32. |
| Group 2 | Active comparator | Drug: EYLEAIntravitreal injection of EYLEA® (aflibercept) will be given at baseline, week 8, 16, 24 and 32. Sham injections will be given at week 1, 4, 12, 20, and 28 in order to maintain masking of patient to treatment assignment |
Who may qualify
- Ages
- 50 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- BCVA 5 - 75 (20/800-20/30), inclusive, in study eye; if both eyes are eligible, the eye with the best potential visual improvement as determined by the investigator will be selected for treatment.
- Presence of choroidal neovascularization secondary to AMD
- At least 3 previous intravitreal anti-VEGF injections in the past 6 months
Key exclusion criteria (15 listed)
- 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.
- Decrease of greater than 150 microns in central subfield thickness as measured by OCT since the last intravitreal injection in the study eye
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-109 | Drug | Group 1 |
| EYLEAAlso: aflibercept | Drug | Group 1, Group 2 |
Primary outcome
Change in Central Subfield Thickness on OCT From Baseline to Week 36
Time frame: baseline to week 36
the amount of change in intraretinal and subretinal fluid as measured by microns of central subfield thickness (CST) on Heidelberg Optical Coherence Tomography (OCT)
1 secondary outcome
Change in Best Corrected Visual Acuity (BCVA) From Baseline to Week 36
Time frame: baseline to week 36
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36604756Rowe LW, Minturn RJ, Burgett LA, Bracha P, Maturi RK. Intravitreal sirolimus with adjunct aflibercept versus aflibercept monotherapy for persistent, exudative age-related macular degeneration: a pilot study. Int J Retina Vitreous. 2023 Jan 5;9(1):1. doi: 10.1186/s40942-022-00437-6.
- 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 and EYLEA in people with Exudative 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 8 inclusion and 15 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 14 Feb 2018. 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 14 Feb 2018). 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 Central Subfield Thickness on OCT From Baseline to Week 36 (time frame: baseline to week 36). 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 NCT02732899, 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 14 Feb 2018; AzTrials last refreshed its copy on 29 Oct 2026.