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Tests treatment safety and results for Diabetic Retinopathy
Official title A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of RO7663498 Following Intravitreal Administration in Participants With Diabetic Retinopathy
ClinicalTrials.gov ID: NCT07588100
What this study is testing
What is RO7663498?
RO7663498 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for diabetic retinopathy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will assess the safety, tolerability, and pharmacokinetics (PK) of intravitreal (IVT) injections of RO7663498 in participants with diabetic retinopathy (DR).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- General Diagnosis of Diabetes Mellitus (DM) (Type 1 or Type 2), as defined by the World Health Organization and/or American Diabetes Association...
- 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.
You likely can't join if
- General Exclusion Criteria:
- Any known hypersensitivity to any of the following compounds: fluorescein; any dilating, anesthetic, or povidone iodine eye drops; or any excipients...
- History of hypersensitivity to biologic agents, the investigational drug, or any of the excipients contained in the formulation administered IVT or...
- 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.
See the full eligibility criteria
- General Diagnosis of Diabetes Mellitus (DM) (Type 1 or Type 2), as defined by the World Health Organization and/or American Diabetes Association Ocular 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Glendale, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Glendale, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.