Study Evaluating the Treatment of OTX-TKI for Subjects With Neovascular Age-related Macular Degeneration

NCT04989699 | Completed Phase 1 FDA Drug

• 1 other identifier: OTX-TKI-2020-101
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 6

Brief Summary

Evaluate the safety, tolerability, and efficacy of OTX-TKI for intravitreal use in subjects with Neovascular Age-Related Macular Degeneration

Conditions

Neovascular Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability

  Incidence and severity of treatment emergent adverse events

  Through study completion, an average of 1 year

Secondary Outcomes (5)

• BCVA changes

  Through study completion, an average of 1 year

• Central subfield thickness changes

  Through study completion, an average of 1 year

• Rescue Therapy

  Through study completion, an average of 1 year

• Absence of Fluid

  Through study completion, an average of 1 year

• Number of injections

  Through study completion, an average of 1 year

Study Arms (2)

OTX-TKI

ACTIVE COMPARATOR

Drug: OTX-TKI/Sham

Aflibercept

ACTIVE COMPARATOR

Drug: Aflibercept/Sham

Interventions

OTX-TKI/Sham DRUG

OTX-TKI is one dose so subsequent visits will be sham to maintain the mask

OTX-TKI

Aflibercept/Sham DRUG

Aflibercept administered every 8 weeks

Also known as: Eylea

Aflibercept

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a diagnosis, within 3 years of screening, of previously treated subfoveal neovascularization (SFNV) secondary to nAMD with leakage involving the fovea, previously treated with documented evidence of an initially favorable clinical response to anti-VEGF therapy (i.e. aflibercept, ranibizumab, brolucizumab, or bevacizumab).
• The macular appearance on OCT is considered to be free of excess intraretinal and/or subretinal fluid as judged by the investigator.
• Must have received at least 3 anti-VEGF injections in the past year.
• Have received the most recent anti-VEGF injection within the past 1-4 weeks prior to screening visit.
• BCVA ETDRS score between 24 and 83 letters (\~20/25 to \~20/320 Snellen equivalent)

You may not qualify if:

• Have evidence of a scar, fibrosis or atrophy of \>50% of the total lesion in the study eye
• Have presence of a disease other than choroidal neovascular membrane (CNVM) due to AMD in the study eye that could affect vision or safety assessments
• Have monocular vision (fellow eye Snellen BCVA is 20/200 or worse

Sponsors & Collaborators

• Ocular Therapeutix, Inc.: lead

Study Sites (6)

Ocular Therapeutix

Bakersfield, California, 93309, United States

Location

Ocular Therapeutix

Oxnard, California, 93036, United States

Location

Ocular Therapeutix

Altamonte Springs, Florida, 32701, United States

Location

Ocular Therapeutix

St. Petersburg, Florida, 33711, United States

Location

Ocular Therapeutix

Reno, Nevada, 89502, United States

Location

Ocular Therapeutix

The Woodlands, Texas, 77384, United States

Location

MeSH Terms

Interventions

aflibercept

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 3:1

Study Record Dates

• First Submitted: July 2, 2021
• First Posted: August 4, 2021
• Study Start: July 28, 2021
• Primary Completion: February 6, 2023
• Study Completion: December 18, 2023
• Last Updated: January 26, 2024

Record last verified: 2024-01

Locations

US (6)