A Study to Investigate RO7200220 in Combination With Ranibizumab in Diabetic Macular Edema
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| ClinicalTrials.gov Identifier: NCT05151744 |
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Recruitment Status :
Recruiting
First Posted : December 9, 2021
Last Update Posted : February 27, 2023
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Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Diabetic Macular Edema | Drug: RO7200220 Drug: Ranibizumab Other: Sham Procedure | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 230 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 in Combination With Ranibizumab Administered Intravitreally in Patients With Diabetic Macular Edema |
| Actual Study Start Date : | December 17, 2021 |
| Estimated Primary Completion Date : | May 31, 2024 |
| Estimated Study Completion Date : | September 30, 2024 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Edema
Drug Information available for:
Ranibizumab
| Arm | Intervention/treatment |
|---|---|
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Experimental: Arm A: RO7200220 + Ranibizumab
Participants will receive RO7200220, 1 milligram (mg) administered as intravitreal (IVT) injection in combination with ranibizumab, 0.5 mg IVT, on Day 1 and every fourth week (Q4W) up to Week 44, for a total of 12 injections, followed by an observational period up to Week 72.
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Drug: RO7200220
RO7200220 will be administered by IVT injection in the study eye. Drug: Ranibizumab Ranibizumab will be administered by IVT injection in the study eye.
Other Name: Lucentis |
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Active Comparator: Arm B: Ranibizumab
Participants will receive ranibizumab, 0.5 mg IVT, from Day 1 and Q4W in combination with sham up to Week 44, for a total of 12 injections, followed by an observational period up to Week 72.
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Drug: Ranibizumab
Ranibizumab will be administered by IVT injection in the study eye.
Other Name: Lucentis 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. |
Primary Outcome Measures :
- Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Averaged Over Week 44 and Week 48, in Treatment-naïve Participants [ Time Frame: Baseline, Week 44 and Week 48 ]
Secondary Outcome Measures :
- Number of Participants with Systemic and Ocular Adverse Events (AEs) [ Time Frame: Up to Week 72 ]
- Number of Participants with Abnormal Laboratory Findings, Abnormal Vital Signs Values, or Abnormal Electrocardiogram (ECG) Parameters [ Time Frame: Up to Week 72 ]
- Number of Participants with Abnormalities in Standard Ophthalmological Assessments [ Time Frame: Up to Week 72 ]
- Mean Change From Baseline in BCVA Averaged Over Week 44 and Week 48, in Previously Treated Participants [ Time Frame: Baseline, Week 44 and Week 48 ]
- Mean Change From Baseline in BCVA Averaged Over Week 44 and Week 48, in Overall Enrolled Population [ Time Frame: Baseline, Week 44 and Week 48 ]
- Mean Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Treatment-naïve Participants [ Time Frame: Baseline, Week 20 and Week 24 ]
- 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 ]
- 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 ]
- Mean Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Treatment-naïve Participants [ Time Frame: Baseline, Week 32 and Week 36 ]
- Mean Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Previously Treated Participants [ Time Frame: Baseline, Week 32 and Week 36 ]
- Mean Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Overall Enrolled Population [ Time Frame: Baseline, Week 32 and Week 36 ]
- Mean Change from Baseline in BCVA Over Time [ Time Frame: From baseline to end of study (up to Week 72) ]
- Percentage of Participants Gaining ≥ 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA Over Time [ Time Frame: From baseline to end of study (up to Week 72) ]
- Percentage of Participants Avoiding a Loss of ≥ 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA Over Time [ Time Frame: From baseline to end of study (up to Week 72) ]
- Percentage of of Participants with BCVA ≥ 69 Letters (20/40 Snellen Equivalent) or ≥ 84 Letters (20/20 Snellen Equivalent) Over Time [ Time Frame: From baseline to end of study (up to Week 72) ]
- Percentage of Participants with BCVA ≤38 Letters (20/200 Snellen Equivalent) Over Time [ Time Frame: From baseline to end of study (up to Week 72) ]
- Change from Baseline in Central Subfield Thickness (CST) at Week 48 [ Time Frame: Baseline, Week 48 ]
- Change from Baseline in CST at Week 36 [ Time Frame: Baseline, Week 36 ]
- Change from Baseline in CST at Week 24 [ Time Frame: Baseline, Week 24 ]
- Mean Change from Baseline in CST Over Time [ Time Frame: From baseline to end of study (up to Week 72) ]
- Percentage of Participants with Absence of Diabetic Macular Edema Over Time [ Time Frame: From baseline to end of study (up to Week 72) ]
- Number of Participants with Absence of Intraretinal Fluid and/or Subretinal Fluid Over Time [ Time Frame: From baseline to end of study (up to Week 72) ]
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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 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
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): NCT05151744
Contacts
| Contact: Reference Study ID Number:BP43464 https://forpatients.roche.com/ | 888-662-6728 (US Only) | global-roche-genentech-trials@gene.com |
Locations
Show 46 study locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT05151744 |
| Other Study ID Numbers: |
BP43464 2021-004390-31 ( EudraCT Number ) |
| First Posted: | December 9, 2021 Key Record Dates |
| Last Update Posted: | February 27, 2023 |
| Last Verified: | February 2023 |
| 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) |
| 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 |