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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06495918




Registration number
NCT06495918
Ethics application status
Date submitted
3/07/2024
Date registered
11/07/2024
Date last updated
17/06/2025

Titles & IDs
Public title
Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects With Neovascular Age- Related Macular Degeneration
Scientific title
A Phase 3, Multicenter, Double-Masked, Randomized, Parallel Group Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects With Neovascular Age- Related Macular Degeneration
Secondary ID [1] 0 0
OTX-TKI-2023-AMD-303
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neovascular Age-related Macular Degeneration 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - OTX-TKI
Treatment: Drugs - Aflibercept
Treatment: Drugs - Aflibercept

Experimental: OTX-TKI Re-dose -

Active comparator: Aflibercept 2mg on label -

Other: Aflibercept 8mg high dose -


Treatment: Drugs: OTX-TKI
Intravitreal Injection of OTX-TKI

Treatment: Drugs: Aflibercept
Intravitreal Injection of 2mg of aflibercept

Treatment: Drugs: Aflibercept
Intravitreal Injection of 8mg of aflibercept
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Best Corrected Visual Acuity (BCVA)
Timepoint [1] 0 0
Week 48

Eligibility
Key inclusion criteria
* Treatment naïve juxtafoveal and/or SFNV secondary to Neovascular Age- Related Macular Degeneration (nAMD) with leakage involving the fovea in the study eye prior to Screening, or have a diagnosis of Neovascular Age- Related Macular Degeneration (nAMD) in study eye within 3 months prior to screening and received up to 2 monthly injections of 2 mg aflibercept with last injection approximately 4 weeks prior to Screening
* Have provided written consent
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Monocular subject or Best Corrected Visual Acuity (BCVA) score of <20 ETDRS letters or 20/400 in fellow eye at Screening
* Have evidence of a scar, fibrosis, or atrophy of >50% of the total lesion in the study eye.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/11/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
8/01/2027
Actual
Sample size
Target
825
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Albury Eye Clinic - Albury
Recruitment hospital [2] 0 0
Marsden Eye Specialists (MES) - Parramatta - Parramatta
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
2150 - Parramatta
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
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California
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Colorado
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Connecticut
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Florida
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Georgia
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Illinois
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Indiana
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Iowa
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Maryland
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Michigan
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Minnesota
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Mississippi
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Missouri
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Nevada
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New Jersey
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New Mexico
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New York
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North Carolina
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Ohio
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Oregon
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Pennsylvania
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South Carolina
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South Dakota
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Tennessee
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Texas
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Utah
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Virginia
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Caba
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Argentina
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Ciudad Autonoma de Buenos Aires
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Argentina
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Ciudad Autonoma de Buenos Aire
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Argentina
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Ciudad de Mendoza
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Argentina
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Mendoza
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Argentina
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Rosario
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Puerto Rico
State/province [37] 0 0
Arecibo

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Ocular Therapeutix, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Fortrea
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Duke University
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Dilsher Dhoot, MD
Address 0 0
California Retina Consultants (CRC) - Santa Barbara
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Clinical Project Manager
Address 0 0
Country 0 0
Phone 0 0
781-357-4000
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06495918