> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-investigate-vamikibart-ro7200220-in-diabetic-602d496f-b703-440d-85f5-bc3029a02482 > Record changed: 2026-10-13 # A Study to Investigate Vamikibart (RO7200220) in Diabetic Macular Edema NCT05151731 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05151731) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05151731) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05151731) Participants 394 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05151731) Lead sponsor Hoffmann-La Roche Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05151731) Start date 2021-12-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05151731) Number of sites 74 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05151731) ## Title and summary **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 vamikibart 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05151731) **Short title** A Study to Investigate Vamikibart (RO7200220) in Diabetic Macular Edema Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05151731) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05151731) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05151731) **Registry reports results** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05151731) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05151731) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05151731) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05151731) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05151731) ## Dates **Completion date** 2025-04-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05151731) **First posted** 2021-12-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05151731) **Registry last updated** 2026-05-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05151731) **Primary completion date** 2024-11-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05151731) **Start date** 2021-12-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05151731) ## Size and sites **Actual participants** 394 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05151731) **Participants** 394 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05151731) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05151731) **Protocol amendments** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05151731) **Number of sites** 74 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05151731) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05151731) **Lead sponsor** Hoffmann-La Roche Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05151731) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05151731) ## Identifiers **Registry ID** NCT05151731 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05151731) **ClinicalTrials.gov ID** NCT05151731 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05151731) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05151731) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Triple masking **Masked roles** Participants, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05151731) ## Outcomes ### Primary outcomes 1. Change From Baseline in Best-Corrected Visual Acuity (BCVA) Averaged Over Week 44 and Week 48, in Treatment-naïve Participants Timeframe: Baseline, Weeks 44 and 48 The BCVA, at a starting test distance of 4 meters (m), was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified early treatment diabetic retinopathy study \\\[ETDRS\\\] charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a Mixed Model for Repeated Measurements (MMRM) model. Adjusted mean has been reported. ### Secondary outcomes 1. Number of Participants With Systemic and Ocular Adverse Events (AEs) Timeframe: Up to Week 72 An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Systemic AEs include all non-ocular AEs. Only one eye was selected as the study eye, while the other was referred to as the fellow eye. 2. Change From Baseline in BCVA Averaged Over Week 44 and Week 48, in Previously Treated Participants Timeframe: Baseline, Weeks 44 and 48 The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported. 3. Change From Baseline in BCVA Averaged Over Week 44 and Week 48, in Overall Enrolled Population Timeframe: Baseline, Weeks 44 and 48 The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported. 4. Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Treatment-naïve Participants Timeframe: Baseline, Weeks 32 and 36 The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported. 5. Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Previously Treated Participants Timeframe: Baseline, Weeks 32 and 36 The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported. 6. Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Overall Enrolled Population Timeframe: Baseline, Weeks 32 and 36 The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported. 7. Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Treatment-naïve Participants Timeframe: Baseline, Weeks 20 and 24 The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported. 8. Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Previously Treated Participants Timeframe: Baseline, Weeks 20 and 24 The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported. 9. Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Overall Enrolled Population Timeframe: Baseline, Weeks 20 and 24 The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported. 10. Change From Baseline in BCVA Over Time, in Overall Enrolled Population Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72 The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported. 11. Percentage of Participants Gaining Greater Than or Equal to (≥) 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA From Baseline Over Time, in Overall Enrolled Population Timeframe: From baseline up to Week 72 The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. Percentages have been summarized. 12. Percentage of Participants Avoiding a Loss of ≥ 15, ≥ 10, or ≥ 5 Letters in BCVA From Baseline Over Time, in Overall Enrolled Population Timeframe: From baseline up to Week 72 The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. Percentages have been summarized. 13. Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time, in Overall Enrolled Population Timeframe: Baseline, Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72 The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 (Snellen equivalent \\<20/800) to 100 (Snellen equivalent of 20/10) letters. A gain in BCVA letter score from baseline indicates an improvement in visual acuity. Percentages have been summarized. 14. Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time, in Overall Enrolled Population Timeframe: Baseline, Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72 The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 (Snellen equivalent \\<20/800) to 100 (Snellen equivalent of 20/10) letters. A gain in BCVA letter score from baseline indicates an improvement in visual acuity. Percentages have been summarized. 15. Percentage of Participants With BCVA of Less Than or Equal to (≤) 38 Letters (Snellen Equivalent 20/200) Over Time, in Overall Enrolled Population Timeframe: Baseline, Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72 The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 (Snellen equivalent \\<20/800) to 100 (Snellen equivalent of 20/10) letters. A gain in BCVA letter score from baseline indicates an improvement in visual acuity. Percentages have been summarized. 16. Change From Baseline in Central Subfield Thickness (CST) Averaged Over Weeks 44 and 48, in Treatment-naïve Participants Timeframe: Baseline, Weeks 44 and 48 CST was defined as the distance between the internal limiting membrane (ILM) and the retinal pigment epithelium (RPE), measured using Spectral Domain-Optical Coherence Tomography (SD-OCT). This analysis used a MMRM model. Adjusted mean has been reported. 17. Change From Baseline in CST Averaged Over Weeks 44 and 48, in Previously Treated Participants Timeframe: Baseline, Weeks 44 and 48 CST was defined as the distance between the ILM and the RPE, measured using SD-OCT. This analysis used a MMRM model. Adjusted mean has been reported. 18. Change From Baseline in CST Averaged Over Weeks 44 and 48, in Overall Enrolled Population Timeframe: Baseline, Weeks 44 and 48 CST was defined as the distance between the ILM and the RPE, measured using SD-OCT. This analysis used a MMRM model. Adjusted mean has been reported. 19. Change From Baseline in CST Averaged Over Weeks 32 and 36, in Treatment-naïve Participants Timeframe: Baseline, Weeks 32 and 36 CST was defined as the distance between the ILM and the RPE, measured using SD-OCT. This analysis used a MMRM model. Adjusted mean has been reported. 20. Change From Baseline in CST Averaged Over Weeks 32 and 36, in Previously Treated Participants Timeframe: Baseline, Weeks 32 and 36 CST was defined as the distance between the ILM and the RPE, measured using SD-OCT. This analysis used a MMRM model. Adjusted mean has been reported. 21. Change From Baseline in CST Averaged Over Weeks 32 and 36, in Overall Enrolled Population Timeframe: Baseline, Weeks 32 and 36 CST was defined as the distance between the ILM and the RPE, measured using SD-OCT. This analysis used a MMRM model. Adjusted mean has been reported. 22. Change From Baseline in CST Averaged Over Weeks 20 and 24, in Treatment-naïve Participants Timeframe: Baseline, Weeks 20 and 24 CST was defined as the distance between the ILM and the RPE, measured using SD-OCT. This analysis used a MMRM model. Adjusted mean has been reported. 23. Change From Baseline in CST Averaged Over Weeks 20 and 24, in Previously Treated Participants Timeframe: Baseline, Weeks 20 and 24 CST was defined as the distance between the ILM and the RPE, measured using SD-OCT. This analysis used a MMRM model. Adjusted mean has been reported. 24. Change From Baseline in CST Averaged Over Weeks 20 and 24, in Overall Enrolled Population Timeframe: Baseline, Weeks 20 and 24 CST was defined as the distance between the ILM and the RPE, measured using SD-OCT. This analysis used a MMRM model. Adjusted mean has been reported. 25. Change From Baseline in CST Over Time, in Overall Enrolled Population Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72 CST was defined as the distance between the ILM and the RPE, measured using SD-OCT. This analysis used a MMRM model. Adjusted mean has been reported. And 3 more, listed on the interactive page. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05151731) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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: