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

  • STATUS
    Recruiting
  • End date
    Jan 15, 2024
  • participants needed
    230
  • sponsor
    Hoffmann-La Roche
Updated on 23 October 2022
Investigator
Reference Study ID Number:BP43464 https://forpatients.roche.com/
Primary Contact
The Retina Centre of Ottawa (3.4 mi away) Contact
+36 other location

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 RO7200220 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.

Details
Condition Diabetic Macular Edema
Treatment ranibizumab, Sham Procedure, RO7200220
Clinical Study IdentifierNCT05151744
SponsorHoffmann-La Roche
Last Modified on23 October 2022

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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