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A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of RO7497372 in Participants With Diabetic Macular Edema (DME)
Eye Disorder Diabetic Macular Edema
Basic Details
Sponsor
Genentech, Inc.
Phase
Phase 1
Study Identifier
NCT06847854, BP44175
Condition
Diabetic Macular Edema
Official Title
A Phase I, Multipart, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7497372 Following Intravitreal Administration in Participants With Diabetic Macular Edema (Part 1 Non-Randomized, Open-Label, Multiple Ascending Dose; Part 2 Randomized, Double-Masked)
Study Summary
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.
Eligibility Criteria
All
≥18 Years
No
Inclusion Criteria
- Diagnosis of diabetes mellitus (type 1 or type 2), as defined by the world health organization (WHO) and/or American Diabetes Association
- Participant consents to AH collection
- Collection of > 90 microlitres (µL) AH (at each visit required per schedule of activities [SoA]) if deemed feasible and safe by the Investigator.
- Macular thickening secondary to DME involving the center of the fovea with CST >= 325 µm at screening
- Decreased BCVA primarily due to DME with ETDRS score of 78 to 19 letters (both inclusive) at screening
- Adequately clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images
- Diagnosis of non-proliferative DR
- Treatment-naive and Pre-treated participants after washout
Exclusion Criteria
- Any major illness or major surgical procedure ≤ 4 weeks before Day 1
- Any febrile illness and associated sequelae ≤ 1 week prior to Day 1
- Active cancer ≤ 1 year prior to Day 1
- Cerebral vascular accident (including stroke and transient ischemic attack) or myocardial infarction ≤ 24 weeks prior to Day 1
- HbA1c ≥ 12% at screening
- Any panretinal photocoagulation or macular laser photocoagulation treatment prior to Day 1
- History of vitreoretinal surgery/pars plana vitrectomy
- Any cataract surgery within 12 weeks prior to Day 1 or any planned surgery during the study
- History of any glaucoma surgery including laser glaucoma procedures
- Uncontrolled glaucoma
- Any active intra- or periocular infection on Day 1
- Any active or history of Intraocular inflammation
- Intravitreal treatment with an anti-IL-6 (e.g., vamikibart) or anti-IL-6 receptor treatment at any time
- Any proliferative DR
The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.
The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
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For the latest version of this information please go to www.forpatients.roche.com