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Trial record 1 of 1 for:    BP43445
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A Study to Investigate RO7200220 in Diabetic Macular Edema

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ClinicalTrials.gov Identifier: NCT05151731
Recruitment Status : Recruiting
First Posted : December 9, 2021
Last Update Posted : July 18, 2022
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: RO7200220 Drug: Ranibizumab Other: Sham Procedure Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : December 31, 2021
Estimated Primary Completion Date : January 15, 2024
Estimated Study Completion Date : January 15, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
Drug Information available for: Ranibizumab

Arm Intervention/treatment
Experimental: Arm A: 0.25 mg RO7200220 Q8W
Participants will receive RO7200220 0.25 milligrams (mg), by Intravitreal (IVT) injection, on Day 1 and every 8th week (Q8W), up to Week 20, for a total of 3 injections. A sham procedure will be administered during study visits at which no study drug is administered to maintain masking between treatment arms.
Drug: RO7200220
RO7200220 will be administered by IVT injection as specified in each treatment arm.

Other: Sham Procedure
Sham is a procedure that mimics an IVT injection and involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. Sham procedure will be administered to participants in the Q8W arms at applicable visits to maintain masking between treatment arms.

Experimental: Arm B: 1.0 mg RO7200220 Q8W
Participants will receive RO7200220 1.0 mg, by IVT injection, on Day 1 and Q8W, up to Week 20, for a total of 3 injections. A sham procedure will be administered during study visits at which no study drug is administered to maintain masking between treatment arms.
Drug: RO7200220
RO7200220 will be administered by IVT injection as specified in each treatment arm.

Other: Sham Procedure
Sham is a procedure that mimics an IVT injection and involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. Sham procedure will be administered to participants in the Q8W arms at applicable visits to maintain masking between treatment arms.

Experimental: Arm C: 1.0 mg RO7200220 Q4W
Participants will receive RO7200220 1.0 mg, by IVT injection, on Day 1 and every 4th week (Q4W), up to Week 20 for a total of 6 injections.
Drug: RO7200220
RO7200220 will be administered by IVT injection as specified in each treatment arm.

Active Comparator: Arm D: 0.5 mg Ranibizumab Q4W
Participants will receive ranibizumab 0.5 mg, by IVT injection, on Day 1 and Q4W, up to Week 20 for a total of 6 injections.
Drug: Ranibizumab
Ranibizumab 0.5 mg will be administered to the participants by IVT injection, as specified in the treatment arm.
Other Name: Lucentis




Primary Outcome Measures :
  1. Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Averaged Over Week 20 and Week 24, in Treatment-naïve Participants [ Time Frame: Baseline, Week 20 and Week 24 ]

Secondary Outcome Measures :
  1. Number of Participants With Systemic and Ocular Adverse Events (AEs) [ Time Frame: From baseline up to end of study (up to Week 48) ]
  2. Number of Participants With Abnormal Laboratory Findings, Abnormal Vital Signs Values, or Abnormal Electrocardiogram (ECG) Parameters [ Time Frame: Baseline, Week 24, and early treatment termination visit (up to Week 48) ]
  3. Number of Participants With Abnormalities in Standard Ophthalmological Assessments [ Time Frame: From baseline up to end of study (up to Week 48) ]
  4. Mean Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Previously Treated Participants [ Time Frame: Baseline, Week 20 and Week 24 ]
  5. Mean Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Overall Enrolled Population [ Time Frame: Baseline, Week 20 and Week 24 ]
  6. Change From Baseline in BCVA Over Time [ Time Frame: From baseline up to end of study (up to Week 48) ]
  7. Percentage of Participants Gaining Greater Than or Equal to (≥) 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA From Baseline Over Time [ Time Frame: From baseline up to end of study (up to Week 48) ]
  8. Percentage of Participants Avoiding a Loss of ≥ 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA From Baseline Over Time [ Time Frame: From baseline up to end of study (up to Week 48) ]
  9. Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent), or ≥ 84 Letters (20/20 Snellen Equivalent) Over Time [ Time Frame: From baseline up to end of study (up to Week 48) ]
  10. Percentage of Participants With BCVA of Less Than or Equal to (≤) 38 Letters (Snellen Equivalent 20/200) Over Time [ Time Frame: From baseline up to end of study (up to Week 48) ]
  11. Change From Baseline in Central Subfield Thickness (CST) at Week 24 [ Time Frame: Baseline, Week 24 ]
  12. Change From Baseline in CST Over Time [ Time Frame: From baseline up to end of study (up to Week 48) ]
  13. Percentage of Participants With Absence of Diabetic Macular Edema (DME) Over Time [ Time Frame: From baseline up to end of study (up to Week 48) ]
  14. Percentage of Participants With Absence of Intraretinal Fluid and/or Subretinal Fluid Over Time [ Time Frame: From baseline up to end of study (up to Week 48) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05151731


Contacts
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Contact: Reference Study ID Number: BP43445 https://forpatients.roche.com/ 888-662-6728 (U.S. Only) global-roche-genentech-trials@gene.com

Locations
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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT05151731    
Other Study ID Numbers: BP43445
2021-003756-16 ( EudraCT Number )
First Posted: December 9, 2021    Key Record Dates
Last Update Posted: July 18, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org/). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).

For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Macular Edema
Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents