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A Study to Investigate RO7200220 in Diabetic Macular Edema

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05151731
Collaborator
(none)
400
Enrollment
50
Locations
4
Arms
24.5
Anticipated Duration (Months)
8
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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 RO7200220 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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
400 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 Administered Intravitreally in Patients With Diabetic Macular Edema
Actual Study Start Date :
Dec 31, 2021
Anticipated Primary Completion Date :
Jan 15, 2024
Anticipated Study Completion Date :
Jan 15, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm A: 0.25 mg RO7200220 Q8W

Participants will receive RO7200220 0.25 milligrams (mg), by Intravitreal (IVT) injection, on Day 1 and every 8th week (Q8W), up to Week 44, for a total of 6 injections. A sham procedure will be administered during study visits at which no study drug is administered to maintain masking between treatment arms.

Drug: RO7200220
RO7200220 will be administered by IVT injection as specified in each treatment arm.

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. Sham procedure will be administered to participants in the Q8W arms at applicable visits to maintain masking between treatment arms.
Experimental: Arm B: 1.0 mg RO7200220 Q8W

Participants will receive RO7200220 1.0 mg, by IVT injection, on Day 1 and Q8W, up to Week 44, for a total of 6 injections. A sham procedure will be administered during study visits at which no study drug is administered to maintain masking between treatment arms.

Drug: RO7200220
RO7200220 will be administered by IVT injection as specified in each treatment arm.

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. Sham procedure will be administered to participants in the Q8W arms at applicable visits to maintain masking between treatment arms.
Experimental: Arm C: 1.0 mg RO7200220 Q4W

Participants will receive RO7200220 1.0 mg, by IVT injection, on Day 1 and every 4th week (Q4W), up to Week 44 for a total of 12 injections.

Drug: RO7200220
RO7200220 will be administered by IVT injection as specified in each treatment arm.
Active Comparator: Arm D: 0.5 mg Ranibizumab Q4W

Participants will receive ranibizumab 0.5 mg, by IVT injection, on Day 1 and Q4W, up to Week 44 for a total of 12 injections.

Drug: Ranibizumab
Ranibizumab 0.5 mg will be administered to the participants by IVT injection, as specified in the treatment arm.
Other Names:
  • Lucentis

    		•

    Outcome Measures

    Primary Outcome Measures

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

    Secondary Outcome Measures

    1. Number of Participants With Systemic and Ocular Adverse Events (AEs) [Up to Week 72]

    2. Number of Participants With Abnormal Laboratory Findings, Abnormal Vital Signs Values, or Abnormal Electrocardiogram (ECG) Parameters [Up to Week 72]

    3. Number of Participants With Abnormalities in Standard Ophthalmological Assessments [Up to Week 72]

    4. Mean Change From Baseline in BCVA Averaged Over Week 44 and Week 48, in Previously Treated Participants [Baseline, Week 44 and Week 48]

    5. Mean Change From Baseline in BCVA Averaged Over Week 44 and Week 48, in Overall Enrolled Population [Baseline, Week 44 and Week 48]

    6. Mean Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Treatment-naïve Participants [Baseline, Week 20 and Week 24]

    7. Mean Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Previously Treated Participants [Baseline, Week 20 and Week 24]

    8. Mean Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Overall Enrolled Population [Baseline, Week 20 and Week 24]

    9. Mean Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Treatment-naïve Participants [Baseline, Week 32 and Week 36]

    10. Mean Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Previously Treated Participants [Baseline, Week 32 and Week 36]

    11. Mean Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Overall Enrolled Population [Baseline, Week 32 and Week 36]

    12. Change From Baseline in BCVA Over Time [From baseline up to end of study (up to Week 72)]

    13. Percentage of Participants Gaining Greater Than or Equal to (≥) 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA From Baseline Over Time [From baseline up to end of study (up to Week 72)]

    14. Percentage of Participants Avoiding a Loss of ≥ 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA From Baseline Over Time [From baseline up to end of study (up to Week 72)]

    15. Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent), or ≥ 84 Letters (20/20 Snellen Equivalent) Over Time [From baseline up to end of study (up to Week 72)]

    16. Percentage of Participants With BCVA of Less Than or Equal to (≤) 38 Letters (Snellen Equivalent 20/200) Over Time [From baseline up to end of study (up to Week 72)]

    17. Change From Baseline in Central Subfield Thickness (CST) at Week 48 [Baseline, Week 48]

    18. Change From Baseline in CST at Week 36 [Baseline, Week 36]

    19. Change From Baseline in CST at Week 24 [Baseline, Week 24]

    20. Change From Baseline in CST Over Time [From baseline up to end of study (up to Week 72)]

    21. Percentage of Participants With Absence of Diabetic Macular Edema (DME) Over Time [From baseline up to end of study (up to Week 72)]

    22. Percentage of Participants With Absence of Intraretinal Fluid and/or Subretinal Fluid Over Time [From baseline up to end of study (up to Week 72)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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; 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Win Retina Arcadia California United States 91006
    2 Retina-Vitreous Associates Medical Group Beverly Hills California United States 90211
    3 Retinal Consultants Med Group Sacramento California United States 95825
    4 Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Torrance California United States 90502
    5 Bay Area Retina Associates Walnut Creek California United States 94598
    6 Emerson Clinical Research Institute LLC Washington District of Columbia United States 20011-3010
    7 Rand Eye Deerfield Beach Florida United States 33064
    8 Pinnacle Research Institute Fort Lauderdale Florida United States 33309
    9 National Ophthalmic Research Institute Fort Myers Florida United States 33912
    10 Florida Retina Institute Orlando Florida United States 32806-1101
    11 Retina Vitreous Associates of Florida Saint Petersburg Florida United States 33711-1141
    12 Butchertown Clinical Trials Louisville Kentucky United States 40206
    13 Cumberland Valley Retina Consultants Hagerstown Maryland United States 21740
    14 Tallman Eye Associates Lawrence Massachusetts United States 01843
    15 Deep Blue Retina PLLC Southaven Mississippi United States 38671
    16 Opthalmic Consultants of LI Lynbrook New York United States 11563
    17 Buffalo Niagara Retina Associates Orchard Park New York United States 14127
    18 Retina Associates of Western New York Rochester New York United States 14620
    19 Western Carolina Retinal Associate PA Asheville North Carolina United States 28803
    20 Meridian Clinical Research Cincinnati Ohio United States 45219
    21 Verum Research LLC Eugene Oregon United States 97401
    22 EyeHealth Northwest Portland Oregon United States 97224
    23 Erie Retinal Surgery Erie Pennsylvania United States 16507
    24 Eye Care Specialists, PC Kingston Pennsylvania United States 18704
    25 Charleston Neuroscience Institute Ladson South Carolina United States 29456
    26 Black Hills Eye Institute Rapid City South Dakota United States 57701
    27 Retina Consultants of Nashville Nashville Tennessee United States 37203
    28 Texas Retina Associates Arlington Texas United States 76012
    29 Austin Clinical Research LLC Austin Texas United States 78750
    30 Retina Consultants of Texas Bellaire Texas United States 77401
    31 Valley Retina Institute P.A. Harlingen Texas United States 78550
    32 Strategic Clinical Research Group, LLC Willow Park Texas United States 76087
    33 Piedmont Eye Center Lynchburg Virginia United States 24502
    34 Organizacion Medica de Investigacion Buenos Aires Argentina C1015ABO
    35 Centro Oftalmológico Dr. Charles S.A. Capital Federal Argentina C1015ABO
    36 Oftalmos Capital Federal Argentina C1120AAN
    37 Buenos Aires Mácula Ciudad Autonoma Buenos Aires Argentina C1061AAE
    38 The Retina Centre of Ottawa Ottawa Ontario Canada K2B 7E9
    39 Toronto Retina Institute Toronto Ontario Canada M3C 0G9
    40 AXON Clinical Prague Czechia
    41 Centrum Medyczne UNO-MED Krakow Poland 31-070
    42 Centrum Diagnostyki i Mikrochirurgii Oka LENS Olsztyn Poland 10-424
    43 Emanuelli Research and Development Center LLC Arecibo Puerto Rico 00612
    44 Hospital General de Catalunya; Servicio de oftalmologia Sant Cugat De Valles Barcelona Spain 08190
    45 Hospital Universitario Puerta de Hierro; Servicio de oftalmologia Majadahonda Madrid Spain 28222
    46 Hospital Universitario Miguel Servet; Servicio de Oftalmologia Zaragoza Spain 50009
    47 Bradford Royal Infirmary Bradford United Kingdom BD9 6RJ
    48 Gloucestershire Hospitals NHS Foundation Trust Gloucestershire United Kingdom GL1 3NN
    49 Royal Surrey County Hospital Guildford United Kingdom GU2 7XX
    50 Moorfields Eye Hospital NHS Foundation Trust London United Kingdom EC1V 2PD

    Sponsors and Collaborators

    • Hoffmann-La Roche

    Investigators

    • Study Director: Clinical Trials, Hoffmann-La Roche

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT05151731
    Other Study ID Numbers:
    • BP43445
    • 2021-003756-16
    First Posted:
    Dec 9, 2021
    Last Update Posted:
    Aug 17, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Macular Edema
    Edema
    Ranibizumab

    Study Results

    No Results Posted as of Aug 17, 2022