Clinical trial NCT04820452: A Study of IBI302 in Patients With nAMD
Official title: A Multi-center, Randomized, Double-blind, Active-controlled Phase II Study to Evaluate the Efficacy and Safety of IBI302 in Subjects With Neovascular Age-related Macular Degeneration
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: 2021-03-29
Enrollment: 231
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: This is a multi-center, randomized, double-blind, active-controlled study to evaluate the efficacy and safety of IBI302 in subjects with neovascular age-related macular degeneration.


Eligibility criteria: Inclusion criteria

1. Male or female patient ≥ 50 yrs. of age.
2. Active subfoveal or parafoveal CNV secondary to neovascular AMD.
3. BCVA score of 24-73 letters using ETDRS charts in the study eye.
4. Willing and able to sign informed consent form and comply with visit and study procedures per protocol.

Exclusion criteria

1. Concomitant diseases that may cause subjects fail to respond to the treatment or confuse the interpretation of the study results;
2. Presence of uncontrolled glaucoma in the study eye (defined as IOP≥25mmHg despite the standardized treatment);
3. Presence of active intraocular or periocular inflammation or infection;
4. Prior any treatment of following in the study eye:

   1. Anti-VEGF therapy or anti-complement therapy within 3 months prior to screening;
   2. Laser photocoagulation within 3 months prior to screening;
   3. Photodynamic therapy or vitreoretinal surgery;
   4. Intraocular glucocorticoid injection within 6 months prior to enrollment;
5. Presence of any systemic disease: including but not limited toactive 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;
6. History of severe hypersensitivity/allergy to active ingredients or any excipients of the study drug, or fluorescein and povidone iodine;
7. Pregnant or lactating women or women preparing to become pregnant or breastfeeding during the study period;
8. 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;
9. Other conditions unsuitable for enrollment judged by investigators

Primary outcomes:
measure: The visual efficacy of IBI302
timeFrame: Baseline to week 36
Secondary outcomes:
measure: other visual effects of IBI302
timeFrame: Baseline to week 52
measure: the anatomical effects of IBI302 on OCT
timeFrame: Baseline to week 52
measure: the anatomical effects of IBI302 on FFA
timeFrame: Baseline to week 52
measure: the safety of IBI302
timeFrame: Baseline to week 52
measure: Immunogenicity of IBI302
timeFrame: Baseline to week 52
Other outcomes:
Locations:
city: Suzhou
country: China
facility: Innovent Biologics (Suzhou) Co,Ltd.
state: Jiangsu
Study officials:
References: