Neovascular Age-Related Macular Degeneration study: OTX-TKI
Official title 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
ClinicalTrials.gov ID: NCT07516132
What this study is testing
What is OTX-TKI?
This is an investigational medicine being studied as a potential treatment for neovascular age-related macular degeneration. is designed to block the growth of new, abnormal blood vessels in the eye.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to determine whether the axitinib implant remains safe over a longer period after the initial 2‑year trial.
- Who it's for
- It is for adults who have neovascular age‑related macular degeneration and who successfully completed the earlier 2‑year OTX‑TKI trials.
- What's involved
- Participants will attend scheduled follow‑up visits where eye exams and safety tests are performed; no new treatment is given beyond the implant already in place.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- Participants with a diagnosis of nAMD in the study eye who successfully completed Study OTX-TKI-2023-AMD-301 through Week 104 or Study...
- 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
You likely can't join if
- 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...
- Presence of an intercurrent illness or condition that in the opinion of the Investigator, may place the participant at an unacceptable risk...
- 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 team makes the final eligibility decision.
Where it is enrolling
- Bakersfield, California, United States
- Santa Barbara, California, United States
- Waterford, Connecticut, United States
- Fort Lauderdale, Florida, United States
- Hagerstown, Maryland, United States
- West Columbia, South Carolina, United States
- Austin, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Bakersfield, California, United States; Santa Barbara, California, United States; Waterford, Connecticut, United States; Fort Lauderdale, Florida, United States; Hagerstown, Maryland, United States; West Columbia, South Carolina, United States and 1 more location. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.