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NCT Number: NCT05972473

A Study to Evaluate the Efficacy and Safety of IBI302 in Subjects With nAMD

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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;
  • 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;
  • 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.

Treatment and study plan

Aflibercept Ophthalmic

Drug

2mg Aflibercept will be administered by intravitreal injection into the study eye once every 4 weeks for 3 consecutive monthes, folloesd by once every 8 weeks(Q8W).

IBI302

Biological

8 mg IBI302 will be administered by intraitreal injection into the study eye at intervals as specified in the study protocol.

Primary outcomes

  1. Mean change from baseline in Best corrected visual acuity ( BCVA ) in the study eye.

    Time frame: At week 44, 48, 52

    Change from Baseline in BCVA as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score at week 44, 48, 52.

Secondary outcomes

  1. The proportion of participants with absence intraretinal fluid (IRF) and absence subretinal fluid (SRF) in the fovea at Week 16

    Time frame: At week 16

    The intraretinal fluid and subretinal fluid is measured by optical coherence tomography (OCT) in the central subfield(center 1 millimeter)

  2. Change from baseline in BCVA at Week 52 and 100

    Time frame: Upto Week 100

    Best corrected visual acuity (BCVA) was measured on early treatment diabetic retinopathy study(ETDRS) chart at a starting distance of 4 meters. The BCVAletter score ranges from 0 to 100(best score), and a gain in BCVA from baseline indicates an improvement in visual acuity.

  3. Change from baseline in central subfield thickness (CST) measured by optical coherence tomography (OCT) at Week 52 and 100

    Time frame: Upto Week 100

    Central subfield thickness was defined as the distance between the internal limiting member and the Bruch's member using OCT, as assessed by the central reading center.

  4. Change from baseline in area of CNV on fundus fluorescence angiography (FFA) at Week 52 and 100

    Time frame: Upto Week 100

    the area of the choroidal neovascularization lesion in the study eye was measured by a central reading center using FFA

  5. Proportion of participants on a q8W, q12W, and q16W treatment intervals at Week 52 and 100

    Time frame: Upto Week 100

    Percentages are based on number of participants randomized to the IBI302 group who have not discontinued the study at week 52 and 100. the treatment interval at a givven visit is defined as the treatment interval decision followed at that visit.

  6. 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).

    Time frame: Upto Week 100

    All AEs were recorded and the investigator made an assessment of seriousness,severity, and causality of each AE.

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Aug 2, 2023
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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