Clinical trial NCT05403749: A Study of Longer Interval of IVT IBI302 in Subjects With nAMD
Official title: A Multi-center, Randomized, Double-masked, Active-controlled Study to Evaluate the Longer Interval of Intravitreal (IVT) Injection of IBI302 in Subjects With Neovascular Age-related Macular Degeneration (nAMD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neovascular Age-related Macular Degeneration
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2022-06-03
Enrollment: 132
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is designed for multi-center, randomized, double-masked, active-controlled study to evaluate the longer interval of intravitreal injection of IBI302 in subjects with neovascular age-related macular degeneration.


Eligibility criteria: Inclusion Criteria:

1. Willing and able to sign informed consent from and comply with visit and study procedures per protocol.
2. Male or female patients≥50 yrs. of age.
3. Active subfoveal or parafoveal CNV secondary to neovascular AMD on FFA or OCT.
4. The CNV area≥50% lesion area on FFA in the study eye at screening visit.
5. BCVA score of 24-78 letters using ETDRS charts in the study eye at the baseline.

Exclusion Criteria:

1. Concomitant diseases that may cause subjects fail to respond to the treatment or confuse the interpretation of the study results.
2. Subretinal hemorrhage\>50% total lesion area and/or involvement in the macular foveal, fibrosis or atrophy area\>50% total lesion area and/or involved of macular fovea;
3. Presence of uncontrolled glaucoma in the study eye(defined as IOP≥25mmHg, or judged by the investigators at the screening or baseline visit)
4. Presence of active intraocular or periocular inflammation or infection;
5. Prior any treatment of following in the study eye:

   * Anti-VEGF(Vascular Endothelial Growth Factor) therapy or anti-complement therapy within 3 months prior to screening;
   * Laser photocoagulation within 3 months prior to screening;
   * Photodynamic therapy or vitreoretinal surgery;
   * Intraocular glucocorticoid injection within 6 months prior to enrollment;
6. Presence of any systemic disease: including but not limited tractive infections (such as active viral hepatitis); unstable angina; cerebrovascular accident or transient cerebral ischemia (within 6 months prior to selection); myocardial infarction (within 6 months prior to selection); serious arrhythmia requiring medical treatment; liver, kidney or metabolic diseases; or malignant tumor;
7. History of severe hypersensitivity/allergy to active ingredients or any excipients of the study drug, or fluorescein and povidone iodine;
8. Pregnant or lactating women or women preparing to become pregnant or breastfeeding during the study period;
9. Participated in any clinical study of any other drug within three months prior to enrollment, or attempted to participate in other drug trials during the study;
10. Other conditions unsuitable for enrollment judged by investigators

Primary outcomes:
measure: Change of BCVA from baseline
timeFrame: Baseline to week 40
Secondary outcomes:
measure: Percentage of Participants Loss >0,≥5,10，15 Letters From the Baseline BCVA in the Study Eye Over Time
timeFrame: Baseline to week 52
measure: Change of Central Subfield Thickness in the Study Eye from baseline
timeFrame: Baseline to week 52
measure: Change of Total Area of Choroidal Neovascularization (CNV) Lesion/Total Area of Choroidal Neovascularization Leakage in the Study Eye from Baseline
timeFrame: From Baseline to week 52
measure: Percentage of Participants in different dosage of IBI302 Arm on Once Every 8-Weeks, 12-Weeks,Treatment Intervals
timeFrame: At Week 20,40,52
measure: Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants
timeFrame: From Baseline to week 52
measure: Percentage of Participants Gaining ≥0,5,10,15 Letters From the Baseline BCVA in the Study Eye Over Time
timeFrame: From Baseline to week 52
measure: Immunogenicity end points
timeFrame: From Baseline to week 52
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai First People's Hospital
state: Shanghai
Study officials:
References: