RO7663498 eye injection safety in diabetic retinopathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human phase 1 trial evaluates intravitreal RO7663498 in adults with diabetic retinopathy to understand safety and pharmacokinetics. Participants receive the drug via eye injections and are monitored for adverse events and how the drug is processed in the body. Inclusion requires diabetes, good visual acuity in the study eye, non-proliferative retinopathy, and enough ocular fluid collection to safely perform injections. Exclusion criteria include known hypersensitivities to the drug or related components.

Why it matters

Who can join: the full rules

Inclusion Criteria:

General Inclusion Criteria

* Diagnosis of Diabetes Mellitus (DM) (Type 1 or Type 2), as defined by the World Health Organization and/or American Diabetes Association

Ocular Inclusion Criteria for the Study Eye

* BCVA score at screening of \>= 19 letters in study eye using Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity testing charts
* Non-proliferative diabetic retinopathy (NPDR) as assessed by the investigator and confirmed by the Central reading center (CRC)
* Collection of \>= 90 micro liter (μL) AH deemed feasible and safe by the investigator.

Exclusion Criteria:

General Exclusion Criteria:

* Any known hypersensitivity to any of the following compounds: fluorescein; any dilating, anesthetic, or povidone iodine eye drops; or any excipients contained in the treatments used in this study.
* History of hypersensitivity to biologic agents, the investigational drug, or any of the excipients contained in the formulation administered IVT or systemically.

Ocular Exclusion Criteria for the Study Eye

* Center-involved Diabetic Macular Edema (DME)
* Any history or concurrent ocular conditions/procedures and/or visual system conditions of the below.
* Vitreoretinal surgery/pars plana vitrectomy.
* Any history of glaucoma surgery or planned glaucoma surgery during the study.
* Uncontrolled glaucoma
* Anterior segment neovascularization.
* Vitreous or preretinal hemorrhage.
* Any ocular disease other than DR and DME that may Confound assessment of the retina in the opinion of the investigator or Confound development of worsening DR, DME, or retinal nonperfusion.
* Any presence of active intraocular inflammation on Day 1 (i.e., Standardization of Uveitis Nomenclature \[SUN\] criteria \> 0 or National Eye Institute \[NEI\] vitreous haze grading \> 0) or any history of IOI.
* Aphakia or previous violation of the posterior capsule in the study eye

Ocular Exclusion Criteria for the Non-study Eye

* BCVA \< 38 letters

Where it's running

• Global Research Management
  Glendale, California, United States Recruiting
• University Retina and Macula Associates, PC
  Oak Forest, Illinois, United States Recruiting
• Ohio State Havener Eye Institute;Ophthalmology Research
  Columbus, Ohio, United States Recruiting
• Medical Center Ophthalmology Associates
  San Antonio, Texas, United States Recruiting

Study contacts

• Study coordinator: Reference Study ID Number: BP46156 https://forpatients.roche.com/ No email attachments.
• Email: global-roche-genentech-trials@gene.com
• Phone: 888-662-6728 (U.S. Only)

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.