Skip to main content
OpenTrials
Completed

NCT Number: NCT05151731

A Study to Investigate Vamikibart (RO7200220) in Diabetic Macular Edema

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetic Macular Edema

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Organizacion Medica de Investigacion, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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: </=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

Treatment and study plan

Vamikibart

Drug

Vamikibart will be administered by IVT injection as specified in each treatment arm.

Other names: RO7200220

ranibizumab

Drug

Ranibizumab 0.5 mg will be administered to the participants by IVT injection, as specified in the treatment arm.

Other names: Lucentis

Sham Procedure

Other

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.

Primary outcomes

  1. Change From Baseline in Best-Corrected Visual Acuity (BCVA) Averaged Over Week 44 and Week 48, in Treatment-naïve Participants

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

  26. Percentage of Participants With Absence of DME Over Time, in Overall Enrolled Population

    Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72

    Absence of DME was defined as CST < 325 µm for spectralis SD-OCT, or < 315 μm for cirrus SD-OCT or topcon SD-OCT. SD-OCT was performed on a Spectralis instrument. Percentages have been summarized.

  27. Percentage of Participants With Absence of Intraretinal Fluid (IRF) Over Time, in Overall Enrolled Population

    Time frame: Baseline, Weeks 4, 12, 24, 36, 48, and 72

    The absence of IRF in the study eye (defined as IRF absent or definite outside center subfield only) was assessed by the central reading center using SD-OCT. The percentage of participants with the absence of IRF at the foveal center were reported. Percentages have been summarized.

  28. Percentage of Participants With Absence of Subretinal Fluid (SRF) Over Time, in Overall ITT Population

    Time frame: Baseline, Weeks 4, 12, 24, 36, 48, and 72

    The absence of SRF in the study eye (defined as SRF absent or definite outside center subfield only) was assessed by the central reading center using SD-OCT. The percentage of participants with absence of SRF at the foveal center were reported. Percentages have been summarized.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Dec 9, 2021
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.