A Study to Investigate RO7200220 in Diabetic Macular Edema

  • Diabetic Macular Edema
Trial Status:

Recruiting

This trial runs in
Cities
  • Arcadia
  • Arecibo
  • Arlington
  • Asheville
  • Austin
  • Bellaire
  • Beverly Hills
  • Bradford
  • Cincinnati
  • erie
  • Eugene
  • Fort Myers
  • Hagerstown
  • Harlingen
  • kingston
  • Lawrence
  • London
  • Louisville
  • Lynchburg
  • Majadahonda
  • Nashville
  • Orlando
  • Pompano Beach
  • Rapid City
  • Rochester
  • Sacramento
  • St. Petersburg
  • Torrance
  • Walnut Creek
  • Washington
  • Zaragoza
Trial Identifier:

NCT05151731 2021-003756-16 BP43445

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

      Results Disclaimer

      Trial Summary

      Study BP43445 is a phase II, multicenter, randomized, double-masked, active comparator-controlled study to investigate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of RO7200220 administered intravitreally in participants with diabetic macular edema. Only one eye will be chosen as the study eye. The duration of the study will be 52 weeks.

      Hoffmann-La Roche Sponsor
      Phase 2 Phase
      NCT05151731 , BP43445 , 2021-003756-16 Trial Identifier
      RO7200220, Ranibizumab, Sham Procedure Treatments
      Diabetic Macular Edema Condition
      Official Title

      A Phase II, Multicenter, Randomized, Double Masked, Active Comparator-Controlled Study to Investigate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7200220 Administered Intravitreally in Patients With Diabetic Macular Edema

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Diagnosis of diabetes mellitus (Type 1 or Type 2)
      • Macular thickening secondary to diabetic macular edema (DME) involving the center of the macula
      • Decreased visual acuity attributable primarily to DME
      • Ability and willingness to provide written informed consent and to comply with the study protocol
      • Willingness to allow Aqueous Humor collection
      • For women of childbearing potential: agreement to remain abstinent or use at least two acceptable contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 12 weeks after the final dose of study treatment
      Exclusion Criteria
      • Hemoglobin A1c (HbA1c) of greater than (>) 12%
      • Uncontrolled blood pressure, defined as a systolic value greater than (>)180 millimeters of mercury (mmHg) and/or a diastolic value >100 mmHg while a patient is at rest
      • Currently pregnant or breastfeeding, or intend to become pregnant during the study
      • Prior treatment with panretinal photocoagulation or macular laser to the study eye
      • Any intraocular or periocular corticosteroid treatment within the past 16 weeks prior to Day 1 to the study eye
      • Prior Iluvien or Retisert implants within 3 years prior to Day 1 to the study eye
      • Prior anti-VEGF treatment within the past 8 weeks prior to Day 1 to the study eye
      • Prior administration of IVT brolucizumab in either eye
      • Any proliferative diabetic retinopathy
      • Active intraocular or periocular infection or active intraocular inflammation in the study eye
      • Any current or history of ocular disease other than DME that may confound assessment of the macula or affect central vision in the study eye
      • Any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than DME in the study eye
      • Other protocol-specified inclusion/exclusion criteria may apply

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