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

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

Detailed Description
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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

Official Title
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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)

Conditions
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Neovascular Age-Related Macular Degeneration

Intervention / Treatment
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* Drug: OTX-TKI/Sham
* Drug: Aflibercept/Sham


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 3:1
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: OTX-TKI<br> | Drug: OTX-TKI/Sham<br>* OTX-TKI is one dose so subsequent visits will be sham to maintain the mask<br>|
| Active Comparator: Aflibercept<br> | Drug: Aflibercept/Sham<br>* Aflibercept administered every 8 weeks<br>* Other names: Eylea;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability | Incidence and severity of treatment emergent adverse events | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BCVA changes | BCVA Changes from Baseline | Through study completion, an average of 1 year | 
| Central subfield thickness changes | Central subfield thickness changes from baseline | Through study completion, an average of 1 year | 
| Rescue Therapy | Proportion of subjects receiving rescue therapy | Through study completion, an average of 1 year | 
| Absence of Fluid | Proportion of subjects with absence of foveal fluid | Through study completion, an average of 1 year | 
| Number of injections | Number of injections from baseline | Through study completion, an average of 1 year |