Diabetic Macular Edema Clinical Trial
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
Verified date | July 2023 |
Source | Innovent Biologics (Suzhou) Co. Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Suspended |
Enrollment | 234 |
Est. completion date | April 30, 2024 |
Est. primary completion date | October 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Peking University People's Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Innovent Biologics (Suzhou) Co. Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence and severity of ocular and non-ocular adverse events. | To evaluate the number of subjects with ocular and non-ocular adverse events, treatment emergent adverse event, adverse event of special interest, serious adverse events; number of subjects with clinical significant abnormal laboratory values, electrocardiograms (pre and post infusions), abnormal vital signs, ophthalmic and physical examinations. | Up to week 20 | |
Primary | DLT in each group | 7 days | ||
Secondary | Change of BCVA from baseline by visit | Best corrected visual acuity (BCVA) was measured on early treatment diabetic retinopathy study(ETDRS) chart at a starting distance of 4 meters. The BCVAletter score ranges from 0 to 100(best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. | through study completion,an average of 20 weeks | |
Secondary | Change of CST from baseline by visit | Central subfield thickness(CST) was defined as the distance between the internal limiting member and the Bruch's member using OCT, as assessed by the central reading. | through study completion,an average of 20 weeks | |
Secondary | Area under the concentration time curve (AUC) and Maximum plasma concentration (Cmax) | through study completion,an average of 20 weeks | ||
Secondary | The ADA and neutralizing antibody | Blood samples were obtained for measurement of anti-drug antibodies (ADAs) to IBI302 by a validated enzyme-linked immunosorbent assay (ELISA). | through study completion,an average of 20 weeks |
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