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Recruiting NCT07275840

A Study to Evaluate the Efficacy and Safety of IBI302inSubjects With nAMD

Phase II Interventional Neovascular Age-related Macular Degeneration

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: IBI302 8mg dose.
Who it may be relevant to
Registry conditions: Neovascular Age-related Macular Degeneration. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An Open-label, Multicenter, Single-arm Phase II Clinical Study Evaluating the Efficacy and Safety of Intravitreal Injection of IBI302 in Participants With Neovascular Age-related Macular Degeneration

Overview

This study is designed for Open-label, multi-center, single-arm Phase II trail to evaluate the efficacy and safety of intravitreal injection of IBI302 in nAMD patients.

Interventions

  • Drug IBI302 8mg dose
    8 mg IBI302 will be administered by intravitreal injection into the study eye once every 4 weeks for 3 consecutive months, followed by once every 8 weeks.

Primary outcome measures

  • Proportion of participants whose best corrected visual acuity (BCVA) of the study eye decreased by less than 15 letters from baseline as measured by the visual acuity chart in the early treatment diabetic retinopathy study (ETDRS) at week 52 [Time frame: Week52]
Secondary outcome measures (12)
  • The changes in BCVA from baseline at each visit [Time frame: Baseline，Weeks 4，8，12，16，20，24，28，32，36，40，44，48 and 52]
  • Proportion of patients with BCVA improvement of ≥0, ≥5, ≥10, and ≥15 ETDRS letters from baseline at week 52 [Time frame: Week52]
  • Proportion of participants with a decrease in BCVA of >0, ≥5, ≥10, and ≥15 ETDRS letters from baseline at week 52 [Time frame: Week52]
  • The change in central subfield thickness of the macula measured by OCT from the baseline at week 52 [Time frame: Week52]
  • Proportion of participants with IRF/SRF/Pigment epithelial detachment (PED) on OCT at Week 52 [Time frame: Week52]
  • Change in choroidal neovascularization (CNV) area on fundus fluorescein angiography (FFA) at week 52 compared to baseline [Time frame: Week52]
  • Change in CNV leakage area on FFA at week 52 compared to baseline [Time frame: Week52]
  • Proportion of participants with new-onset MA on OCT at Week 52 [Time frame: Week52]
  • Proportion of new-onset fibrosis on color fundus photography (CFP) at Week 52 [Time frame: Week52]
  • Change in MA area on OCT from baseline at Week 52 [Time frame: Week52]
  • Change in fibrosis area and maximum lesion diameter on CFP from baseline at Week 52 [Time frame: Week52]
  • The incidence rate, correlation with the studied drugs, and severity of ocular and systemic adverse events (AE), treatment emergent adverse events (TEAE), and serious adverse events (SAE) [Time frame: From baseline through Week 52]

Eligibility criteria

Inclusion criteria

  • Have signed an informed consent form before participating in the research.
  • Male or female individuals aged 50 or above at the time of signing the informed consent form;
  • Active CNV under the macular fovea secondary to nAMD or active CNV involving the macular fovea.
  • At baseline, the BCVA of the study eye was within the range of 19 to 78 ETDRS letters (including both ends).

Exclusion criteria

  • According to the investigator's judgment, concomitant ocular diseases/systemic diseases of the study eyes at screening or baseline may lead to participants' non-response to the study treatment or confuse the interpretation of the study results;
  • The study eye has uncontrollable glaucoma;
  • There is an active intraocular or periocular infection or inflammation in either eye;
  • The non-study eye has severe visual function disorders;
  • Within 90 days before baseline, the study eye had received anti-VEGF treatment;
  • Within 90 days before baseline, the study eye had received anti-complement treatment;
  • At any time before baseline, the study eye had received IBI302 treatment;
  • Uncontrollable hypertension;
  • Glycated hemoglobin (HbA1c) > 10.0% within 28 days prior to screening;
  • Other exclusion criteria set by protocol.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Shanghai general hospital — Shanghai

Identifiers

NCT: NCT07275840 · CIBI302A203

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗