Neovascular Age-Related Macular Degeneration (nAMD)
Conditions
Keywords
Neovascular Age-Related Macular Degeneration, Tyrosine Kinase Inhibitor, OTX-TKI
Brief summary
Study to Evaluate Long-Term Safety of Intravitreal OTX-TKI (Axitinib Implant) in Participants with Neovascular Age-Related Macular Degeneration Who Successfully Completed 2-Year OTX-TKI-2023-AMD-301 or OTX-TKI-2023-AMD-303 Study
Interventions
DRUGOTX-TKI
Intravitreal Injection of OTX-TKI
Sponsors
Ocular Therapeutix, Inc.
Fortrea
Duke Reading Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants with a diagnosis of nAMD in the study eye who successfully completed Study OTX-TKI-2023-AMD-301 through Week 104 or Study OTX-TKI-2023-AMD-303 through Week 96 * Have adequate ocular media and adequate pupillary dilation in the study eye to permit good quality fundus imaging * Are able and willing to comply with all study requirements and visits * Have provided written informed consent
Exclusion criteria
* Have significant intraocular or periocular infection (bacterial, viral, or fungal) in the study eye within 3 months prior to Day 1 * History of intraocular inflammation in the study eye * Have evidence of a rhegmatogenous retinal detachment or visually significant/severe epiretinal membrane, macular hole, tear of the retinal pigment epithelium in the macula, or other macular * Presence of an intercurrent illness or condition that in the opinion of the Investigator, may place the participant at an unacceptable risk, preventing the participant from completing the study or confound the interpretation of study results * Female participants who are pregnant (had a positive urine test at the Baseline visit \[Day 1\]) or breastfeeding or intend to become pregnant during the study, who are unwilling to use 2 forms of highly effective contraception from baseline until they exit the study or at least 3 months after the last study treatment, whichever is later.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of treatment-emergent adverse events (TEAEs) from Baseline (Day 1) through Week 144 | from Baseline (Day 1) through Week 144 | Number of events |
| Proportion of participants with severe vision loss (defined as ≥ 30 Early Treatment Diabetic Retinopathy Study [ETDRS] letters loss) from Baseline (Day 1) through Week 144 | from Baseline (Day 1) through Week 144 | Percentage |
Countries
United States
Contacts
CONTACTClinical Project Manager
CONTACTNichole Wilkes
PRINCIPAL_INVESTIGATORDilsher Dhoot, MD
California Retina Consultants (CRC)-Santa Barbara
Outcome results
None listed