RECRUITINGPhase 2INTERVENTIONAL
A Study to Evaluate the Efficacy and Safety of IBI302inSubjects With nAMD
An Open-label, Multicenter, Single-arm Phase II Clinical Study Evaluating the Efficacy and Safety of Intravitreal Injection of IBI302 in Participants With Neovascular Age-related Macular Degeneration
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
1. Have signed an willing to sign a consent form form before participating in the research.
2. Male or female individuals aged 50 or above at the time of signing the willing to sign a consent form form;
3. Active CNV under the macular fovea secondary to nAMD or active CNV involving the macular fovea.
4. At baseline, the BCVA of the study eye was within the range of 19 to 78 ETDRS letters (including both ends).
Who Should NOT Join This Trial:
1. 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 interpretation of the study results;
2. The study eye has uncontrollable glaucoma;
3. There is an active intraocular or periocular infection or inflammation in either eye;
4. The non-study eye has severe visual function disorders;
5. Within 90 days before baseline, the study eye had received anti-VEGF treatment;
6. Within 90 days before baseline, the study eye had received anti-complement treatment;
7. At any time before baseline, the study eye had received IBI302 treatment;
8. Uncontrollable hypertension;
9. Glycated hemoglobin (HbA1c) \> 10.0% within 28 days prior to screening;
10. Other exclusion criteria set by protocol.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
1. Have signed an informed consent form before participating in the research.
2. Male or female individuals aged 50 or above at the time of signing the informed consent form;
3. Active CNV under the macular fovea secondary to nAMD or active CNV involving the macular fovea.
4. At baseline, the BCVA of the study eye was within the range of 19 to 78 ETDRS letters (including both ends).
Exclusion Criteria:
1. 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 interpretation of the study results;
2. The study eye has uncontrollable glaucoma;
3. There is an active intraocular or periocular infection or inflammation in either eye;
4. The non-study eye has severe visual function disorders;
5. Within 90 days before baseline, the study eye had received anti-VEGF treatment;
6. Within 90 days before baseline, the study eye had received anti-complement treatment;
7. At any time before baseline, the study eye had received IBI302 treatment;
8. Uncontrollable hypertension;
9. Glycated hemoglobin (HbA1c) \> 10.0% within 28 days prior to screening;
10. Other exclusion criteria set by protocol.
Treatments Being Tested
DRUG
IBI302 8mg dose
8 mg IBI302 will be administered by intravitreal injection into the study eye once every 4 weeks for 3 consecutive months, followed by once every 8 weeks.
Locations (1)
Shanghai general hospital
Shanghai, Shanghai Municipality, China