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NCT05403749CompletedPhase 2

A Study of Longer Interval of IVT IBI302 in Subjects With nAMD

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)

Source: ClinicalTrials.gov · Last updated 28 Jun 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
132 (actual)
First submitted
20 May 2022
Start date
29 Jun 2022
Primary completion date
13 May 2024
Lead sponsor
Innovent Biologics (Suzhou) Co. Ltd.
NCT number
NCT05403749

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 132
  • From 29 Jun 2022 to the primary completion date, 13 May 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Concomitant diseases that may cause subjects fail to respond to the treatment or confuse the interpretation of the study results.
  • 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;
  • 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;
  • 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 illness

  • 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;
  • Presence of active intraocular or periocular inflammation or infection;
  • History of severe hypersensitivity/allergy to active ingredients or any excipients of the study drug, or fluorescein and povidone iodine;
  • Other conditions unsuitable for enrollment judged by investigators

Other

  • Presence of uncontrolled glaucoma in the study eye(defined as IOP≥25mmHg, or judged by the investigators at the screening or baseline visit)
  • Pregnant or lactating women or women preparing to become pregnant or breastfeeding during the study period;

Who the study is looking for

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

Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Shanghai First People's Hospital
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.