Clinical trial NCT05961007: Evaluation of IBI302 Injection in nAMD or DME
Official title: A Dose Escalation Study to Evaluate the Safety and Tolerability of IBI302 Intravitreal Injection in Subjects With Neovascular Age-related Macular Degeneration and Diabetic Macular Edema AND A Multi-center, Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy and Safety of IBI302 in Subjects With Diabetic Macular Edema
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE1
PHASE2
Conditions: Neovascular Age-related Macular Degeneration
Diabetic Macular Edema
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2023-07-27
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the efficacy and safety of intravitreal IBI302 in the treatment of subjects with neovascular age-related macular degeneration (only in Phase I) or diabetic macular edema.


Eligibility criteria: Inclusion criteria

1. Willing and able to sign informed consent form and comply with visit and study procedures per protocol;
2. Male or female patiensubjects ≥ 18 yrs. of age;
3. For AMD subjects, active subfoveal or parafoveal CNV secondary to neovascular AMD; the vision decreased by nAMD;
4. For DME subjects, Type 1 or type 2 diabetes mellitus, decrease in vision determined to be primarily the result of DME in the study eye; the CST measurement of ≥ 280 μm in the study eye;
5. BCVA ETDRS letter score of 24-73 in the study eye;

Exclusion criteria

1. Concomitant diseases that may cause subjects fail to respond to the treatment or confuse the interpretation of the study results;
2. Presence of uncontrolled glaucoma in the study eye ;
3. Presence of active intraocular or periocular inflammation or infection;
4. Prior any treatment of following in the study eye:

   1. Anti-VEGF therapy or anti-complement therapy;
   2. Laser photocoagulation;
   3. History of vitreoretinal surgery;
   4. Glucocorticoid treatment(intravitreal or peribulbar) ;
5. BCVA score \<19 letters in the fellow eye;
6. Anti-VEGF therapy in the fellow eye within 30 days of day 0;
7. Presence of any systemic disease: including but not limited to active infections (such as active viral hepatitis); unstable angina; cerebrovascular accident or transient cerebral ischemia (within 6 months prior to screening); myocardial infarction (within 6 months prior to screening; serious arrhythmia requiring medical treatment; liver, kidney or metabolic diseases; uncontrolled clinical disease(such as diabetes mellitus, hypertension) or malignant tumor;
8. History of severe hypersensitivity/allergy to active ingredients or any excipients of the study drug, or fluorescein and povidone iodine;
9. Pregnant or lactating women or women preparing to become pregnant or breastfeeding during the study period;
10. Participated in any clinical study of any other drug within 90 days of day 0, or attempted to participate in other drug trials during the study;
11. Other conditions unsuitable for enrollment judged by investigatiors.

Primary outcomes:
measure: Incidence and severity of ocular and non-ocular adverse events.
timeFrame: Up to week 20
measure: DLT in each group
timeFrame: 7 days
Secondary outcomes:
measure: Change of BCVA from baseline by visit
timeFrame: through study completion，an average of 20 weeks
measure: Change of CST from baseline by visit
timeFrame: through study completion，an average of 20 weeks
measure: Area under the concentration time curve (AUC) and Maximum plasma concentration (Cmax)
timeFrame: through study completion，an average of 20 weeks
measure: The ADA and neutralizing antibody
timeFrame: through study completion，an average of 20 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
References: