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OpenTrials
Completed

NCT Number: NCT04820452

A Study of IBI302 in Patients With nAMD

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Innovent Biologics (Suzhou) Co,Ltd.

Suzhou, Jiangsu, 215123, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • Concomitant diseases that may cause subjects fail to respond to the treatment or confuse the interpretation of the study results;
  • Presence of uncontrolled glaucoma in the study eye (defined as IOP≥25mmHg despite the standardized treatment);
  • Presence of active intraocular or periocular inflammation or infection;
  • Prior any treatment of following in the study eye:
  • Anti-VEGF 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;
  • 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;
  • History of severe hypersensitivity/allergy to active ingredients or any excipients of the study drug, or fluorescein and povidone iodine;
  • Pregnant or lactating women or women preparing to become pregnant or breastfeeding during the study period;
  • 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;
  • Other conditions unsuitable for enrollment judged by investigators

Treatment and study plan

Low dose IBI302

Biological

Low dose IBI302 intravitreal injection given as every other month after three loading monthly injection

High dose IBI302

Biological

High dose IBI302 intravitreal injection given as every other month after three loading monthly injection

aflibercept

Drug

Intraocular injection

Primary outcomes

  1. The visual efficacy of IBI302

    Time frame: Baseline to week 36

Secondary outcomes

  1. other visual effects of IBI302

    Time frame: Baseline to week 52

    the proportion if BCVA improvement ≥0,5,10 or 15 letters at week 12, 28, 36 and 52.

  2. the anatomical effects of IBI302 on OCT

    Time frame: Baseline to week 52

    the mean change of central subfield thickness from BL to week 52 at week 12, 28, 36 and 52

  3. the anatomical effects of IBI302 on FFA

    Time frame: Baseline to week 52

    the change of CNV area, CNV leakage area, total lesion area from BL to week 36 or 52

  4. the safety of IBI302

    Time frame: Baseline to week 52

    the incidence of ocular AE or any systemic AE, TEAE, SAE

  5. Immunogenicity of IBI302

    Time frame: Baseline to week 52

    the positive rate of anti-drug antibody and neutralizing antibody

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 29, 2021
Registry last updated
Nov 18, 2024

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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