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Recruiting NCT07516132

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

Phase III Interventional Neovascular Age-Related Macular Degeneration (nAMD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: OTX-TKI.
Who it may be relevant to
Registry conditions: Neovascular Age-Related Macular Degeneration (nAMD). Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 3b, Multicenter, Open-Label, Extension 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

Overview

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

  • Drug OTX-TKI
    Intravitreal Injection of OTX-TKI

Primary outcome measures

  • Incidence and severity of treatment-emergent adverse events (TEAEs) from Baseline (Day 1) through Week 144 [Time frame: from Baseline (Day 1) through Week 144]
  • 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 [Time frame: from Baseline (Day 1) through Week 144]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 8 centers
  • California Retina Consultants (CRC) — Bakersfield
  • California Retina Consultants (CRC) — Santa Barbara
  • Retina Group of New England — Waterford
  • Retina Group of Florida - Fort Lauderdale — Fort Lauderdale
  • Cumberland Valley Retina Associates — Hagerstown
  • Mid Atlantic Retina Specialists — Hagerstown
  • Palmetto Retina Center — West Columbia
  • Austin Retina Associates — Austin

Identifiers

NCT: NCT07516132 · OTX-TKI-2025-AMD-301 · SOL-X

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗