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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
187
Vamikibart will be administered by IVT injection in the study eye.
Ranibizumab will be administered by IVT injection in the study eye.
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.
Change From Baseline in Best Corrected Visual Acuity (BCVA) Averaged Over Week 44 and Week 48 in Treatment-naïve Participants
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.
Time frame: Baseline, Week 44 and Week 48
Number of Participants With Systemic and Ocular Adverse Events (AEs)
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.
Time frame: Up to Week 72
Change From Baseline in BCVA Averaged Over Week 44 and Week 48 in Previously Treated Participants
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.
Time frame: Baseline, Week 44 and Week 48
Change From Baseline in BCVA Averaged Over Week 44 and Week 48 in Overall ITT Population
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.
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Win Retina
Arcadia, California, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, United States
Bay Area Retina Associates
Walnut Creek, California, United States
Florida Eye Associates
Melbourne, Florida, United States
Retina Vitreous Associates of Florida
Tampa, Florida, United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, United States
Deep Blue Retina PLLC
Southaven, Mississippi, United States
Verum Research LLC
Eugene, Oregon, United States
Texas Retina Associates
Arlington, Texas, United States
Retina Consultants of Texas
Bellaire, Texas, United States
...and 28 more locations
Time frame: Baseline, Week 44 and Week 48
Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Treatment-naïve Participants
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.
Time frame: Baseline, Week 32 and Week 36
Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Previously Treated Participants
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.
Time frame: Baseline, Week 32 and Week 36
Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Overall ITT Population
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.
Time frame: Baseline, Week 32 and Week 36
Change From Baseline in BCVA Averaged Over Week 20 and Week 24 in Treatment-naïve Participants
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.
Time frame: Baseline, Week 20 and Week 24
Change From Baseline in BCVA Averaged Over Week 20 and Week 24 in Previously Treated Participants
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.
Time frame: Baseline, Week 20 and Week 24
Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Overall ITT Population
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.
Time frame: Baseline, Week 20 and Week 24
Change From Baseline in BCVA Over Time in Overall ITT Population
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.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Percentage of Participants Gaining ≥ 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA Over Time in Overall ITT Population
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.
Time frame: Up to Week 72
Percentage of Participants Losing ≥ 15, ≥ 10, or ≥ 5 Letters in BCVA Over Time in Overall ITT Population
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.
Time frame: Up to Week 72
Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time
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.
Time frame: Baseline, Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time
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.
Time frame: Baseline, Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Percentage of Participants With BCVA ≤ 38 Letters (20/200 Snellen Equivalent) Over Time
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.
Time frame: Baseline, Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Change From Baseline in Central Subfield Thickness (CST) Averaged Over Week 44 and Week 48 in Treatment-naïve Participants
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.
Time frame: Baseline, Week 44 and Week 48
Change From Baseline in CST Averaged Over Week 44 and Week 48 in Previously Treated Participants
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.
Time frame: Baseline, Week 44 and Week 48
Change From Baseline in CST Averaged Over Week 44 and Week 48 in Overall ITT Population
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.
Time frame: Baseline, Week 44 and Week 48
Change From Baseline in CST Averaged Over Week 32 and Week 36 in Treatment-naïve Participants
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.
Time frame: Baseline, Week 32 and Week 36
Change From Baseline in CST Averaged Over Week 32 and Week 36 in Previously Treated Participants
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.
Time frame: Baseline, Week 32 and Week 36
Change From Baseline Averaged Over Week 32 and Week 36 in Overall ITT Population
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.
Time frame: Baseline, Week 32 and Week 36
Change From Baseline in CST Averaged Over Week 20 and Week 24 in Treatment-naïve Participants
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.
Time frame: Baseline, Week 20 and Week 24
Change From Baseline in CST Averaged Over Week 20 and Week 24 in Previously Treated Participants
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.
Time frame: Baseline, Week 20 and Week 24
Change From Baseline in CST Averaged Over Week 20 and Week 24 in Overall ITT Population
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.
Time frame: Baseline, Week 20 and Week 24
Change From Baseline in CST Over Time in Overall ITT Population
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.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Percentage of Participants With Absence of DME Over Time in Overall ITT Population
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.
Time frame: Baseline, Weeks 4, 8, 12, 16, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Percentage of Participants With Absence of Intraretinal Fluid (IRF) Over Time in Overall ITT Population
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.
Time frame: Baseline, Weeks 4, 12, 24, 36, 48, and 72
Percentage of Participants With Absence of Subretinal Fluid (SRF) Over Time in Overall ITT Population
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.
Time frame: Baseline, Weeks 4, 12, 24, 36, 48, and 72