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

Neovascular Age-Related Macular Degeneration Clinical Trial

Official title:

A Prospective Multicenter, Double-Masked, Randomized, Parallel-Group, Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-TKI (Axitinib Implant) for Intravitreal Use in Subjects With Neovascular Age-Related Macular Degeneration (nAMD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04989699
• Other study ID #: OTX-TKI-2020-101
• Status: Completed
• Phase: Phase 1
• Start date: July 28, 2021
• Est. completion date: December 18, 2023

Study information

• Verified date: January 2024
• Source: Ocular Therapeutix, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Multicenter, double masked, randomized, parallel-group study to evaluate the safety, tolerability, and efficacy of OTX-TKI for intravitreal use in subjects with Neovascular Age-Related Macular Degeneration

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 18, 2023
• Est. primary completion date: February 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-Related Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• OTX-TKI/Sham
OTX-TKI is one dose so subsequent visits will be sham to maintain the mask
• Aflibercept/Sham
Aflibercept administered every 8 weeks

Locations

Country	Name	City	State
United States	Ocular Therapeutix	Altamonte Springs	Florida
United States	Ocular Therapeutix	Bakersfield	California
United States	Ocular Therapeutix	Oxnard	California
United States	Ocular Therapeutix	Reno	Nevada
United States	Ocular Therapeutix	Saint Petersburg	Florida
United States	Ocular Therapeutix	The Woodlands	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Ocular Therapeutix, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability	Incidence and severity of treatment emergent adverse events	Through study completion, an average of 1 year
Secondary	BCVA changes	BCVA Changes from Baseline	Through study completion, an average of 1 year
Secondary	Central subfield thickness changes	Central subfield thickness changes from baseline	Through study completion, an average of 1 year
Secondary	Rescue Therapy	Proportion of subjects receiving rescue therapy	Through study completion, an average of 1 year
Secondary	Absence of Fluid	Proportion of subjects with absence of foveal fluid	Through study completion, an average of 1 year
Secondary	Number of injections	Number of injections from baseline	Through study completion, an average of 1 year