A Phase 1 interventional study of RO7497372 in Diabetic Macular Edema, sponsored by Genentech, Inc.. Active, not recruiting at 38 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Genentech, Inc. · Phase 1, Interventional, and Treatment
This study will assess the safety and tolerability of RO7497372 in participants with DME. The study consists of 2 parts. Part 1 will test multiple-ascending doses of RO7497372 after unilateral intravitreal (IVT) administration in participants with DME. The main purpose of Part 1 is to provide data for RO7497372 safety and tolerability, as well as to characterize the ocular and systemic pharmacokinetics (PK), systemic anti-drug antibodies (ADA), and duration of target engagement, i.e., the pharmacodynamics (PD) in aqueous humor (AH) and blood. Part 2 will evaluate the safety, tolerability, PK, and PD of two dose strengths of RO7497372 (low dose and high dose), identified as safe and tolerated in Part 1.
Genentech, Inc. is the lead sponsor of 507 studies on the registry; 23 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 50 (56%) have results posted.
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Exclusion Criteria:
Participants will receive multiple ascending doses of RO7497372, 3 times every 4 weeks (Q4W) as an IVT injection up to Week 8 in the study eye.
Drug: RO7497372
Participants will receive 6 doses of RO7497372, low dose, Q4W followed by 3 doses, every eight weeks (Q8W) as an IVT injection up to Week 44 in the study eye.
Drug: RO7497372
Participants will receive 6 doses of RO7497372, high dose, Q4W followed by 3 doses, Q8W as an IVT injection up to Week 44 in the study eye. Treatment in this arm has been discontinued due to the Sponsor's decision.
Drug: RO7497372
RO7497372 will be administered as IVT injection as per the schedule specified in the arms.
Part 1: Number of Participants With Adverse Events (AEs)
Time frame: Up to 28 Weeks
Part 2: Number of Participants With Intraocular Inflammation (IOI) AEs as Reported by the Investigator
Time frame: Baseline to Week 48
Part 2: Number of Participants With Severe or Serious Drug-Related IOI AEs
Number of participants with severe or serious drug-related IOI AEs severity will be determined according to the DAIDS toxicity grading scale as reported by the Investigator.
Time frame: Baseline to Week 48
Part 2: Number of Participants With Occlusive Retinal Vasculitis AEs as Reported by the Investigator
Time frame: Baseline to Week 48
Part 1: Concentration of RO7497372 in Blood
Time frame: Up to Week 28
Part 1: Concentration of RO7497372 in Aqueous Humor (AH)
Time frame: Up to Week 28
Part 2: Number of Participants With AEs
Number of participants with AEs severity determined according to the DAIDS toxicity grading scale.
Time frame: Up to 56 weeks
Part 2: Number of Participants With Persistent Treatment-induced Anti-drug Antibody (ADAs)
Time frame: Up to 56 weeks
Part 2: Concentration of RO7497372 in AH
Time frame: Up to Week 56
Part 2: Concentration of RO7497372 in Plasma
Time frame: Up to Week 56
Part 2: Change From Baseline in Best Corrected Visual Acuity (BCVA) Score Over Time
BCVA will be measured via Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters using a set of three Precision VisionTM or lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity (VA) examiner. The range of EDTRS is 0 to 100 letters. Higher scores indicates improvement in VA.
Time frame: From Baseline (Day 1) up to Week 56
Part 2: Absolute Value of BCVA Score Over Time
BCVA will be measured via ETDRS chart at a starting distance of 4 meters using a set of three Precision VisionTM or lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified VA examiner. The range of EDTRS is 0 to 100 letters. Higher scores indicates improvement in VA.
Time frame: Up to Week 56
Part 2: Percentage of Participants Gaining ≥ 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA From Baseline Over Time
BCVA will be measured via ETDRS chart at a starting distance of 4 meters using a set of three Precision VisionTM or lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified VA examiner. The range of EDTRS is 0 to 100 letters. Higher scores indicates improvement in VA.
Time frame: Up to Week 56
Part 2: Percentage of Participants Avoiding a Loss of ≥ 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA From Baseline Over Time
BCVA will be measured via ETDRS chart at a starting distance of 4 meters using a set of three Precision VisionTM or lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified VA examiner. The range of EDTRS is 0 to 100 letters. Higher scores indicates improvement in VA.
Time frame: Up to Week 56
Part 2: Change From Baseline in Central Subfield Thickness (CST) Over Time
CST is defined as the average thickness of the central 1-mm circle of the ETDRS grid centered to the fovea measured between the internal limiting membrane and the Bruch's membrane. CST will be determined by CRC evaluation of SD-OCT images.
Time frame: From Baseline (Day 1) up to Week 56
Part 2: Absolute Value of CST Over Time
CST is defined as the average thickness of the central 1-mm circle of the ETDRS grid centered to the fovea measured between the internal limiting membrane and the Bruch's membrane. CST will be determined by CRC evaluation of SD-OCT images.
Time frame: Up to Week 56
Part 2: Percentage of Participants With Absence of DME Over Time
Absence of DME is defined as CST \< 325 micrometre (μm) by spectral domain optical coherence tomography (SD-OCT).
Time frame: Up to Week 56
Part 2: Percentage of Participants With Absence of Intraretinal Fluid and/or Subretinal Fluid Over Time
Presence of intraretinal and subretinal fluid will be determined by CRC evaluation of SD -OCT images.
Time frame: Up to Week 56
Part 2: Percentage of Participants With ≥ 2-step Diabetic Retinopathy Severity Scale (DRSS) Improvement From Baseline on the ETDRS DRSS Over Time
The DRSS will be graded according to ETDRS grading schedules from report 18 JOVS, February 1998, Vol. 39, No. 2. ETDRS DRSS is 13 step scale which measures severity of diabetic retinopathy (DR). The DRSS scores vary from 10 (DR absent) to 90 (ungradable proliferative diabetic retinopathy(PDR)). Higher levels indicate higher severity.
Time frame: Up to Week 56
Plan to share: No
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Genentech, Inc.