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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age50+
SponsorOcular Therapeutix, Inc.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • OTX-TKI

    Drug

    Intravitreal Injection of OTX-TKI

Treatment groups

850 Participants
are divided into 1 treatment group
Group A: OTX-TKIExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence and severity of treatment-emergent adverse events (TEAEs) from Baseline (Day 1) through Week 144

Number of events

Time frame
from Baseline (Day 1) through Week 144
2

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

Percentage

Time frame
from Baseline (Day 1) through Week 144

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ocular Therapeutix, Inc.

Lead sponsor

Fortrea

Collaborator

Duke Reading Center

Collaborator