NCT02357342

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 6, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
5 months until next milestone

Results Posted

Study results publicly available

June 5, 2017

Completed
Last Updated

June 22, 2017

Status Verified

June 1, 2017

Enrollment Period

1.8 years

First QC Date

February 2, 2015

Results QC Date

February 23, 2017

Last Update Submit

June 20, 2017

Conditions

Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (2)

  • 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

    Baseline to 6 months

  • Visual Acuity

    number of subjects with gain of 0-4 letters of visual acuity

    Baseline to 6 months

Secondary Outcomes (1)

  • Visual Acuity (Best Corrected Visual Acuity)

    baseline to 6 months

Study Arms (2)

Sirolimus

EXPERIMENTAL

Intravitreal Sirolimus

Drug: Sirolimus

Standard of Care intravitreal anti-VEGF

ACTIVE COMPARATOR

anti-VEGF intravitreal injections

Drug: Standard of Care intravitreal injections of anti-VEGF

Interventions

SirolimusDRUG

intravitreal injection

Also known as: DE-109
Sirolimus
Standard of Care intravitreal injections of anti-VEGFDRUG

intravitreal injections of anti-VEGF

Also known as: avastin,bevacizumab, eylea, aflibercept,
Standard of Care intravitreal anti-VEGF

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Raj K Maturi MD PC

Indianapolis, Indiana, 46290, United States

Location

Related Publications (1)

  • 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.

    PMID: 33593448DERIVED

MeSH Terms

Conditions

Macular Degeneration

Interventions

SirolimusBevacizumabaflibercept

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic ChemicalsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Raj K. Maturi, MD
Organization
Raj K. Maturi, MD, PC
rmaturi@gmail.com
317-817-1414

Study Officials

  • Raj K Maturi, MD

    Raj K. Maturi, MD, PC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDIV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2015

First Posted

February 6, 2015

Study Start

April 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

June 22, 2017

Results First Posted

June 5, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)