Clinical trial NCT04989699: Study Evaluating the Treatment of OTX-TKI for Subjects With Neovascular Age-related Macular Degeneration
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neovascular Age-Related Macular Degeneration
Lead sponsor: Ocular Therapeutix, Inc.
Sponsor class: INDUSTRY
First posted: 2021-08-04
Enrollment: 21
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3:1
Primary purpose: TREATMENT

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

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Safety and Tolerability
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: BCVA changes
timeFrame: Through study completion, an average of 1 year
measure: Central subfield thickness changes
timeFrame: Through study completion, an average of 1 year
measure: Rescue Therapy
timeFrame: Through study completion, an average of 1 year
measure: Absence of Fluid
timeFrame: Through study completion, an average of 1 year
measure: Number of injections
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Ocular Therapeutix
state: California
city: Oxnard
country: United States
facility: Ocular Therapeutix
state: California
city: Altamonte Springs
country: United States
facility: Ocular Therapeutix
state: Florida
city: Saint Petersburg
country: United States
facility: Ocular Therapeutix
state: Florida
city: Reno
country: United States
facility: Ocular Therapeutix
state: Nevada
city: The Woodlands
country: United States
facility: Ocular Therapeutix
state: Texas
Study officials:
References: