A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) … (NCT06847854) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of RO7497372 in Participants With Diabetic Macular Edema (DME)
United States, Puerto Rico151 participantsStarted 2022-12-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 perio…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Part 1: Number of Participants With Adverse Events (AEs)
Timeframe: Up to 28 Weeks
2
Part 2: Number of Participants With Intraocular Inflammation (IOI) AEs as Reported by the Investigator
Timeframe: Baseline to Week 48
3
Part 2: Number of Participants With Severe or Serious Drug-Related IOI AEs
Timeframe: Baseline to Week 48
4
Part 2: Number of Participants With Occlusive Retinal Vasculitis AEs as Reported by the Investigator