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OpenTrials
Completed

NCT Number: NCT04370379

Trial to Evaluate the Safety and Tolerability of Repeated Intravitreal Injection of IBI302 in Neovascular AMD Patients

This study is designed for multi-center, open-label, randomized, dose escalation phase I trial to evaluate the safety and tolerability of a multiple dose intravitreal injection of IBI302 in neovascular AMD patients.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

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

Inclusion criteria

  • Male or female patient ≥ 50 yrs. of age.
  • Active subfoveal or parafoveal CNV secondary to neovascular AMD.
  • Willing and able to sign informed consent form and comply with visit and study procedures per protocol.

Exclusion criteria

  • Presence of uncontrolled glaucoma in the study eye (defined as IOP≥30mmHg despite the standardized treatment);
  • 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;
  • 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;
  • Diabetic patients have any of the following conditions:HbA1c>7.5% when screening;

Treatment and study plan

IBI302 (the first dose level)

Drug

q4week (3 injections) followed by PRN dosing

IBI302 (the second dose level)

Drug

q4week (3 injections) followed by PRN dosing

aflibercept

Drug

2mg, q4week (3 injections) followed by q8week

Primary outcomes

  1. Ocular safety, assessed by BCVA, slitlamp examination, ophthalmoscopy, IOP, fundus photography

    Time frame: Baseline to Day140

  2. Incidence of adverse events

    Time frame: Baseline to Day140

Secondary outcomes

  1. Changes in central subfield thickness by OCT compared with baseline

    Time frame: Baseline to Day140

  2. Changes in CNV characteristics and CNV area by FA compared with baseline

    Time frame: Baseline to Day140

  3. Changes in BCVA compared with baseline

    Time frame: Baseline to Day140

  4. Positive rate of anti-drug antibody and neutralizing antibody of IBI302

    Time frame: Baseline to Day140

  5. the area under the drug-time curve from 0 to time t of IBI302

    Time frame: Baseline to Day140

  6. the area under the curve at the time of 0-infinity of IBI302

    Time frame: Baseline to Day140

  7. The peak concentration of IBI302

    Time frame: Baseline to Day140

  8. The peak time of IBI302

    Time frame: Baseline to Day140

  9. Clearance rate of IBI302

    Time frame: Baseline to Day140

  10. Half-life of IBI302

    Time frame: Baseline to Day140

  11. VEGF concentration

    Time frame: Baseline to Day140

  12. Concentration of complement fragments

    Time frame: Baseline to Day140

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study title

A Dose Escalation Phase I Clinical Study to Evaluate the Tolerability and Safety of IBI302 in Patients With Neovascular Age-related Macular Degeneration (nAMD)

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 30, 2020
Registry last updated
Nov 11, 2021

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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