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OpenTrials
Completed

NCT Number: NCT05151744

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

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 vamikibart 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.

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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

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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 in the study eye.

Other names: RO7200220

ranibizumab

Drug

Ranibizumab will be administered by IVT injection in the study eye.

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.

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, Week 44 and Week 48

    BCVA was measured via Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters using a set of three Precision vision^TM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity (VA) examiner. The BCVA letter score ranges from 0 to 100 letters. Higher scores and gain in BCVA from baseline indicate improvement in VA. This analysis used a Mixed Model for Repeated Measurements (MMRM) model.

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, regardless of causal attribution. 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.

  2. Change From Baseline in BCVA Averaged Over Week 44 and Week 48 in Previously Treated Participants

    Time frame: Baseline, Week 44 and Week 48

    BCVA was measured via ETDRS chart at a starting distance of 4 meters using a set of three Precision vision^TM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified VA examiner. The BCVA letter score ranges from 0 to 100 letters. Higher scores and gain in BCVA from baseline indicate improvement in VA. This analysis used a MMRM model.

  3. Change From Baseline in BCVA Averaged Over Week 44 and Week 48 in Overall ITT Population

    Time frame: Baseline, Week 44 and Week 48

    BCVA was measured via ETDRS chart at a starting distance of 4 meters using a set of three Precision vision^TM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified VA examiner. The BCVA letter score ranges from 0 to 100 letters. Higher scores and gain in BCVA from baseline indicate improvement in VA. This analysis used a MMRM model.

  4. Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Treatment-naïve Participants

    Time frame: Baseline, Week 32 and Week 36

    BCVA was measured via ETDRS chart at a starting distance of 4 meters using a set of three Precision vision^TM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified VA examiner. The BCVA letter score ranges from 0 to 100 letters. Higher scores and gain in BCVA from baseline indicate improvement in VA. This analysis used a MMRM model.

  5. Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Previously Treated Participants

    Time frame: Baseline, Week 32 and Week 36

    BCVA was measured via ETDRS chart at a starting distance of 4 meters using a set of three Precision vision^TM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified VA examiner. The BCVA letter score ranges from 0 to 100 letters. Higher scores and gain in BCVA from baseline indicate improvement in VA. This analysis used a MMRM model.

  6. Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Overall ITT Population

    Time frame: Baseline, Week 32 and Week 36

    BCVA was measured via ETDRS chart at a starting distance of 4 meters using a set of three Precision vision^TM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified VA examiner. The BCVA letter score ranges from 0 to 100 letters. Higher scores and gain in BCVA from baseline indicate improvement in VA. This analysis used a MMRM model.

  7. Change From Baseline in BCVA Averaged Over Week 20 and Week 24 in Treatment-naïve Participants

    Time frame: Baseline, Week 20 and Week 24

    BCVA was measured via ETDRS chart at a starting distance of 4 meters using a set of three Precision vision^TM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified VA examiner. The BCVA letter score ranges from 0 to 100 letters. Higher scores and gain in BCVA from baseline indicate improvement in VA. This analysis used a MMRM model.

  8. Change From Baseline in BCVA Averaged Over Week 20 and Week 24 in Previously Treated Participants

    Time frame: Baseline, Week 20 and Week 24

    BCVA was measured via ETDRS chart at a starting distance of 4 meters using a set of three Precision vision^TM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified VA examiner. The BCVA letter score ranges from 0 to 100 letters. Higher scores and gain in BCVA from baseline indicate improvement in VA. This analysis used a MMRM model.

  9. Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Overall ITT Population

    Time frame: Baseline, Week 20 and Week 24

    BCVA was measured via ETDRS chart at a starting distance of 4 meters using a set of three Precision vision^TM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified VA examiner. The BCVA letter score ranges from 0 to 100 letters. Higher scores and gain in BCVA from baseline indicate improvement in VA. This analysis used a MMRM model.

  10. Change From Baseline in BCVA Over Time in Overall ITT Population

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

    BCVA was measured via ETDRS chart at a starting distance of 4 meters using a set of three Precision vision^TM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified VA examiner. The BCVA letter score ranges from 0 to 100 letters. Higher scores and gain in BCVA from baseline indicate improvement in VA. This analysis used a MMRM model.

  11. Percentage of Participants Gaining ≥ 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA Over Time in Overall ITT Population

    Time frame: Up to Week 72

    BCVA was measured via ETDRS chart at a starting distance of 4 meters using a set of three Precision vision^TM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified VA examiner. The BCVA letter score ranges from 0 to 100 letters. Higher scores indicate improvement in VA. Percentages have been rounded off.

  12. Percentage of Participants Losing ≥ 15, ≥ 10, or ≥ 5 Letters in BCVA Over Time in Overall ITT Population

    Time frame: Up to Week 72

    BCVA was measured via ETDRS chart at a starting distance of 4 meters using a set of three Precision vision^TM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified VA examiner. The BCVA letter score ranges from 0 to 100 letters. Higher scores indicate improvement in VA. Percentages have been rounded off.

  13. Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time

    Time frame: Baseline, Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72

    BCVA was measured via ETDRS chart at a starting distance of 4 meters using a set of three Precision vision^TM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified VA examiner. The BCVA letter score ranges from 0 (Snellen equivalent <20/800) to 100 (Snellen equivalent of 20/10) letters. Higher scores indicate improvement in VA. Percentages have been rounded off.

  14. Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time

    Time frame: Baseline, Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72

    BCVA was measured via ETDRS chart at a starting distance of 4 meters using a set of three Precision vision^TM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified VA examiner. The BCVA letter score ranges from 0 (Snellen equivalent <20/800) to 100 (Snellen equivalent of 20/10) letters. Higher scores indicate improvement in VA. Percentages have been rounded off.

  15. Percentage of Participants With BCVA ≤ 38 Letters (20/200 Snellen Equivalent) Over Time

    Time frame: Baseline, Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72

    BCVA was measured via ETDRS chart at a starting distance of 4 meters using a set of three Precision vision^TM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified VA examiner. The BCVA letter score ranges from 0 (Snellen equivalent <20/800) to 100 (Snellen equivalent of 20/10) letters. Higher scores indicate improvement in VA. Percentages have been rounded off.

  16. Change From Baseline in Central Subfield Thickness (CST) Averaged Over Week 44 and Week 48 in Treatment-naïve Participants

    Time frame: Baseline, Week 44 and Week 48

    CST was defined as the mean thickness from the inner limiting membrane to the retinal pigment epithelial over the 1 millimetre (mm) central subfield. CST was measured using spectral domain optical coherence tomography (SD-OCT). Negative change from baseline values denotes improvement. This analysis used a MMRM model.

  17. Change From Baseline in CST Averaged Over Week 44 and Week 48 in Previously Treated Participants

    Time frame: Baseline, Week 44 and Week 48

    CST was defined as the mean thickness from the inner limiting membrane to the retinal pigment epithelial over the 1 mm central subfield. CST was measured using SD-OCT. Negative change from baseline values denotes improvement. This analysis used a MMRM model.

  18. Change From Baseline in CST Averaged Over Week 44 and Week 48 in Overall ITT Population

    Time frame: Baseline, Week 44 and Week 48

    CST was defined as the mean thickness from the inner limiting membrane to the retinal pigment epithelial over the 1 mm central subfield. CST was measured using SD-OCT. Negative change from baseline values denotes improvement. This analysis used an MMRM model.

  19. Change From Baseline in CST Averaged Over Week 32 and Week 36 in Treatment-naïve Participants

    Time frame: Baseline, Week 32 and Week 36

    CST was defined as the mean thickness from the inner limiting membrane to the retinal pigment epithelial over the 1 mm central subfield. CST was measured using SD-OCT. Negative change from baseline values denotes improvement. This analysis used an MMRM model.

  20. Change From Baseline in CST Averaged Over Week 32 and Week 36 in Previously Treated Participants

    Time frame: Baseline, Week 32 and Week 36

    CST was defined as the mean thickness from the inner limiting membrane to the retinal pigment epithelial over the 1 mm central subfield. CST was measured using SD-OCT. Negative change from baseline values denotes improvement. This analysis used an MMRM model.

  21. Change From Baseline Averaged Over Week 32 and Week 36 in Overall ITT Population

    Time frame: Baseline, Week 32 and Week 36

    CST was defined as the mean thickness from the inner limiting membrane to the retinal pigment epithelial over the 1 mm central subfield. CST was measured using SD-OCT. Negative change from baseline values denotes improvement. This analysis used an MMRM model.

  22. Change From Baseline in CST Averaged Over Week 20 and Week 24 in Treatment-naïve Participants

    Time frame: Baseline, Week 20 and Week 24

    CST was defined as the mean thickness from the inner limiting membrane to the retinal pigment epithelial over the 1 mm central subfield. CST was measured using SD-OCT. Negative change from baseline values denotes improvement. This analysis used an MMRM model.

  23. Change From Baseline in CST Averaged Over Week 20 and Week 24 in Previously Treated Participants

    Time frame: Baseline, Week 20 and Week 24

    CST was defined as the mean thickness from the inner limiting membrane to the retinal pigment epithelial over the 1 mm central subfield. CST was measured using SD-OCT. Negative change from baseline values denotes improvement. This analysis used an MMRM model.

  24. Change From Baseline in CST Averaged Over Week 20 and Week 24 in Overall ITT Population

    Time frame: Baseline, Week 20 and Week 24

    CST was defined as the mean thickness from the inner limiting membrane to the retinal pigment epithelial over the 1 mm central subfield. CST was measured using SD-OCT. Negative change from baseline values denotes improvement. This analysis used an MMRM model.

  25. Change From Baseline in CST Over Time in Overall ITT Population

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

    CST was defined as the mean thickness from the inner limiting membrane to the retinal pigment epithelial over the 1 mm central subfield. CST was measured using SD-OCT. Negative change from baseline values denotes improvement. This analysis used an MMRM model.

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

    Time frame: Baseline, Weeks 4, 8, 12, 16, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 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. Percentages have been rounded off.

  27. Percentage of Participants With Absence of Intraretinal Fluid (IRF) Over Time in Overall ITT 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 absence of IRF at foveal center are reported. Percentages have been rounded off.

  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 are reported. Percentages have been rounded off.

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 in Combination With Ranibizumab Administered Intravitreally in Patients With Diabetic Macular Edema

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Dec 9, 2021
Registry last updated
Oct 16, 2025

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.

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