A Study to Investigate RO7200220 in Combination With Ranibizumab in Diabetic Macular Edema

A Study to Investigate Vamikibart (RO7200220) in Combination With Ranibizumab in Diabetic Macular Edema

  • Eye Disorder
  • Diabetic Macular Edema
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Completed

This trial runs in
Countries
  • Argentina
  • Canada
  • Israel
  • Poland
  • Puerto Rico
  • South Korea
  • Spain
  • United Kingdom
  • United States
Trial Identifier:

NCT05151744 2021-004390-31 BP43464

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      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 trial 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 below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Trial Summary

      Study BP43464 is a phase II, multicenter, randomized, double-masked active comparator-controlled study designed to assess the efficacy, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of vamikibart in combination with, anti-vascular endothelial growth factor (VEGF) inhibitor, ranibizumab compared with ranibizumab alone in participants with diabetic macular edema. Only one eye will be chosen as the study eye. The duration of the study will be 76 weeks.

      Hoffmann-La Roche Sponsor
      Phase 2 Phase
      NCT05151744, BP43464, 2021-004390-31 Trial Identifier
      Vamikibart, 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 in Combination With Ranibizumab 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 one highly effective contraceptive method that results 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 or concomitant treatment with anti-VEGF therapy within 8 weeks prior to Day 1 to the study eye; Vabysmo^TM within 16 weeks prior to Day 1, prior Beovu® is not permitted
      • Prior administration of IVT brolucizumab (Beovu®): ever; vamikibart: </=24 weeks prior to Day 1) 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

      For the latest version of this information please go to www.forpatients.roche.com

       

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