Clinical trial NCT05972473: A Study to Evaluate the Efficacy and Safety of IBI302 in Subjects With nAMD
Official title: A Phase 3, Randomized, Double-masked, Active-Controlled Study to Evaluate the Efficacy and Safety of Intravitreal IBI302(Efdamrofusp Alfa) in Subjects With Neovascular Age-Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Neovascular Age-related Macular Degeneration
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2023-08-02
Enrollment: 600
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-contralled study to evaluate effective and security of intravitreal injection of IBI302 in subjects with neovascular age-related macular degeneration.


Eligibility criteria: Inclusion Criteria:

1. Signed informed consent must be obtained prior to study participation;
2. Male or female ≥ 50 years of age at the time of signing the informed consent;
3. Active subfoveal CNV secondary to nAMD, or active CNV with intra/subretinal fluid involving the fovea;
4. BCVA of 19 to 78 ETDRS letters (inclusive) in the study eye at baseline.

Exclusion Criteria:

1. Ocular disease:

   * Any concurrent intraocular condition/systemic disease in the study eye at screening or baseline that, in the judgment of the investigator, may cause the participant fail to respond to the treatment or confuse the interpretation of study results;
   * Total lesion area(including blood, atrophy, fibrosis, PED and neovascularization)\> 12 optic disc area (DA) on FFA;
   * Subretinal hemorrhage area \> 50% of the total lesion area, or subretinal hemorrhage area involving macular fovea ≥ 1 DA;
   * Fibrosis or atrophy area \> 50% of the total lesion area, or involving the fovea; Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg after standard treatment);
   * Presence of active intraocular or periocular infection or inflammation;
2. Ocular treatment:

   * Anti-VEGF or anti-complement therapy in the study eye within 90 days prior to baseline;
   * Fundus laser photo-coagulation in the study eye within 90 days prior to baseline;
   * Photodynamic Therapy (PDT) in the study eye within 90 days prior to baseline;
   * History of vitreoretinal surgery, penetrating keratoplasty in the study eye;
3. General condition or treatment:

   * Uncontrolled hypertension (defined as systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg after standard treatment);
   * HbA1c \> 8% within 28 days prior to baseline; Systemic anti-VEGF drug and anti-complement drug therapy within 90 days prior to baseline;
   * History of hypersensitivity to any component of the test article, control article, or clinically relevant sensitivity to fluorescein dye, povidone-iodine;
   * Pregnant or lactating women; Inappropriate for the study (e.g., substance abuse, inability or unwillingness to follow the trial protocol), as judged by the investig.

Primary outcomes:
measure: Mean change from baseline in Best corrected visual acuity ( BCVA ) in the study eye.
timeFrame: At week 44, 48, 52
Secondary outcomes:
measure: The proportion of participants with absence intraretinal fluid (IRF) and absence subretinal fluid (SRF) in the fovea at Week 16
timeFrame: At week 16
measure: Change from baseline in BCVA at Week 52 and 100
timeFrame: Upto Week 100
measure: Change from baseline in central subfield thickness (CST) measured by optical coherence tomography (OCT) at Week 52 and 100
timeFrame: Upto Week 100
measure: Change from baseline in area of CNV on fundus fluorescence angiography (FFA) at Week 52 and 100
timeFrame: Upto Week 100
measure: Proportion of participants on a q8W, q12W, and q16W treatment intervals at Week 52 and 100
timeFrame: Upto Week 100
measure: Incidence, relatedness to the study drug and severity of ocular and Non-ocular adverse events (AE), treatment emergent adverse events (TEAE) and serious adverse events (SAE).
timeFrame: Upto Week 100
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
Study officials:
References: