None listed
Conditions
Interventions
Drug : The investigational product (Vabysmo® 6 mg, 0.05 mL) will be administered via intravitreal injection. During the loading phase, a total of four injections will be administered at 4-week interva
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who are intravitreal (IVT) treatment-naïve in the study eye 2) Diabetic macular edema (DME) is defined as macular thickening by spectral-domain optical coherencetomography (SD-OCT) involving the center of the macula. This inclusion criterion is to be assessed by theinvestigators. 3) Diabetic choroidopathy (DC) defined as qualitative features by Ultra-Widefield (UWF) ICGA. Thisinclusion criterion is to be assessed by the investigators 4) Decreased visual acuity (VA) attributable primarily to DME 5) Clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images toconfirm diagnosis 6) Diagnosis of diabetes mellitus (Type 1 or Type 2), as defined by the World Health Organization (WHO)and/or American Diabetes Association 7) Hemoglobin A1c (HbA1c) =10% 8) Signed Informed Consent Form 9) Participants who are able to comply with the study protocol, in the investigator’s Judgment 10) For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexualintercourse) or use contraception (will be defined in details in protocol)
Exclusion criteria
Exclusion criteria: 1) Any concurrent ocular condition in the study eye which, in the opinion of the investigator, could eitherincrease the risk to the patient beyond what is to be expected from standard procedures of intraocularinjection, or which otherwise may interfere with the injection procedure or with evaluation of efficacy orsafety. 2) Any ocular or periocular infection within the last 2 weeks prior to Screening in either eye. 3) Prior vitrectomy in the study eye 4) Any intraocular or periocular surgery within 3 months of Day 1 on the study eye, except lid surgery, whichmay not have taken place within 1 month of day 1, as long as it’s unlikely to interfere with the injection. 5) Prior trabeculectomy or other filtration surgery in the study eye. 6) Uncontrolled glaucoma (defined as intraocular pressure = 25 mmHg despite treatment with antiglaucomamedication) in the study eye. 7) Active intraocular inflammation in either eye. 8) Active ocular or periocular infection in either eye. 9) Aphakia or pseudophakia with absence of posterior capsule (unless it occurred as a result of an yttriumaluminum garnet [YAG] posterior capsulotomy) in the study eye. 10) Currently untreated diabetes mellitus or previously untreated patients who initiated oral or injectable anti-diabetic medication within 3 months prior to Day 11) Any prior or concomitant systemic anti-VEGF treatment within 6 months or 5 half-lives prior to Day 1 12) Any known hypersensitivity to any of the components in the faricimab injection, dilating eye drops, or any of the anesthetics and antimicrobial preparations used by the patient during the study. 13) Any major illness or major surgical procedure within 1 month before the Day 1. 14) One re-screening for this criterion is permitted. 15) Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after thefinal dose of faricimab. 16) Any condition resulting in a compromised immune system that is likely to impact the aqueous humor (AH)inflammatory biomarkers. 17) Patients who are currently enrolled in or have participated in any other clinical study involving aninvestigational product or device, or in any other type of medical research, within 3 months or 5 half-livesprior to Day 1 and up to completion of the current study. 18) Use of systemic immunomodulatory treatments (i.e. TNF-a) within 6 months or 5 half-lives prior to Day 1. 19) Use of systemic medications known to be toxic to the lens, retina or optic nerve used during the 6-monthperiod or 5 half-lives prior to Day 1 or likely need to be used. 20) Received a blood transfusion within 3 months prior to the screening visit 21) Active cancer within the past 12 months prior to Day 1 except for appropriately treated carcinoma in situ ofthe cervix, non-melanoma skin carcinoma, and prostate cancer with a Gleason score of =6 and a stableprostate-specific antigen for >12 months 22) Stroke or myocardial infarction within 12 months prior to Day 1. One re-screening for this criterion ispermitted 23) Any febrile illness within 1 week prior to Day 1. One re-screening for this criterion is permitted 24) History of other diseases, other non-diabetic metabolic dysfunction, physical examination finding, historicalor current clinical laboratory finding giving reasonable suspicion of a condition that contraindicates the useof the faricimab or that might affect interpretation of the results of the study or renders the patient at high-risk for treatment complications, in the opi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the change inaqueous humor (AH) endothelialextracellular vesicle (EV) ANG-2levels following faricimabadministration | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in AH EV-Ang2 and non-EV Ang2 concentrations;Change from baseline in AH non-EV angiogenic and inflammatory protein concentrations;Change in BCVA based on ETDRS letter score;Proportion of subjects achieving =2-step improvement in DRSS;Proportion of subjects achieving =1-step improvement in DCSS;Change in CST;Proportion of subjects with resolution of central IRF/SRF;Changes in microaneurysm count, deep capillary plexus vessel density, and peripheral non-perfusion area;Changes in choroidal vascular structure and perfusion parameters;Mean number of investigational product administrations;Proportion of subjects achieving treatment intervals of =12 weeks or =16 weeks without disease activity;Distribution of maximum treatment intervals in subjects without disease activity | — |
Countries
Korea, Republic of
Contacts
Public Contactminkyung kang
Asan Medical Center
Outcome results
None listed