Health TrialsbyHealthPanel

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

ConditionNeovascular Age-related Macular Degeneration
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age50+
SponsorInnovent Biologics Technology Limited (Shanghai R&D Center)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • IBI302 8mg dose

    Drug

    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.

Treatment groups

800 Participants
are divided into 1 treatment group
Group A: IBI302 8mg dose 8mgExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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 outcomes

1

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
2

Proportion of patients with BCVA improvement of ≥0, ≥5, ≥10, and ≥15 ETDRS letters from baseline at week 52

Time frame
Week52
3

Proportion of participants with a decrease in BCVA of >0, ≥5, ≥10, and ≥15 ETDRS letters from baseline at week 52

Time frame
Week52
4

The change in central subfield thickness of the macula measured by OCT from the baseline at week 52

Time frame
Week52

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Innovent Biologics Technology Limited (Shanghai R&D Center)

Lead sponsor

Source ClinicalTrials.gov
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