Neovascular Age-Related Macular Degeneration
Conditions
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
Interventions
DRUGOTX-TKI/Sham
OTX-TKI is one dose so subsequent visits will be sham to maintain the mask
DRUGAflibercept/Sham
Aflibercept administered every 8 weeks
Sponsors
Ocular Therapeutix, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
3:1
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability | Through study completion, an average of 1 year | Incidence and severity of treatment emergent adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BCVA changes | Through study completion, an average of 1 year | BCVA Changes from Baseline |
| Central subfield thickness changes | Through study completion, an average of 1 year | Central subfield thickness changes from baseline |
| Rescue Therapy | Through study completion, an average of 1 year | Proportion of subjects receiving rescue therapy |
| Absence of Fluid | Through study completion, an average of 1 year | Proportion of subjects with absence of foveal fluid |
| Number of injections | Through study completion, an average of 1 year | Number of injections from baseline |
Countries
United States
Outcome results
None listed