A Study to Investigate RO7200220 in Diabetic Macular Edema

  • STATUS
    Recruiting
  • End date
    Apr 17, 2025
  • participants needed
    400
  • sponsor
    Hoffmann-La Roche
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Updated on 20 September 2023
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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 up to 76 weeks.

Details
Condition Diabetic Macular Edema
Treatment ranibizumab, Sham Procedure, RO7200220
Clinical Study IdentifierNCT05151731
SponsorHoffmann-La Roche
Last Modified on20 September 2023

Eligibility

 Yes No Not Sure

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; RO7200220: </=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
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