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Tests treatment safety and results for Neovascular Age-related Macular Degeneration
Official title A Study to Evaluate the Efficacy and Safety of IBI302inSubjects With nAMD
ClinicalTrials.gov ID: NCT07275840
What this study is testing
What is IBI302 8mg dose?
IBI302 8mg dose is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for neovascular age-related macular degeneration.
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
- This study is designed for Open-label, multi-center, single-arm Phase II trail to evaluate the efficacy and safety of intravitreal injection of IBI302 in nAMD patients.
- Phase 2: a mid-size study of how well it works
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
- Have signed an informed consent form before participating in the research.
- Male or female individuals aged 50 or above at the time of signing the informed consent form;
- Active CNV under the macular fovea secondary to nAMD or active CNV involving the macular fovea.
- At baseline, the BCVA of the study eye was within the range of 19 to 78 ETDRS letters (including both ends).
You likely can't join if
- According to the investigator's judgment, concomitant ocular diseases/systemic diseases of the study eyes at screening or baseline may lead to...
- The study eye has uncontrollable glaucoma;
- There is an active intraocular or periocular infection or inflammation in either eye;
- The non-study eye has severe visual function disorders;
- Within 90 days before baseline, the study eye had received anti-VEGF treatment;
- Within 90 days before baseline, the study eye had received anti-complement treatment;
See the full eligibility criteria
- Have signed an informed consent form before participating in the research.
- Male or female individuals aged 50 or above at the time of signing the informed consent form;
- Active CNV under the macular fovea secondary to nAMD or active CNV involving the macular fovea.
- At baseline, the BCVA of the study eye was within the range of 19 to 78 ETDRS letters (including both ends).
- According to the investigator's judgment, concomitant ocular diseases/systemic diseases of the study eyes at screening or baseline may lead to participants' non-response to the study treatment or confuse the...
- The study eye has uncontrollable glaucoma;
- There is an active intraocular or periocular infection or inflammation in either eye;
- The non-study eye has severe visual function disorders;
- Within 90 days before baseline, the study eye had received anti-VEGF treatment;
- Within 90 days before baseline, the study eye had received anti-complement treatment;
- At any time before baseline, the study eye had received IBI302 treatment;
- Uncontrollable hypertension;
- Glycated hemoglobin (HbA1c) \> 10.0% within 28 days prior to screening;
- Other exclusion criteria set by protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
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 - 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?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.