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

Primary Purpose

Diabetic Macular Edema

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
RO7200220
Ranibizumab
Sham Procedure
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Win Retina
  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
  • Bay Area Retina Associates
  • Florida Eye Associates
  • Retina Vitreous Associates of Florida
  • Cumberland Valley Retina Consultants
  • Deep Blue Retina PLLC
  • Verum Research LLC
  • Texas Retina Associates
  • Retina Consultants of Texas
  • Rocky Mountain Retina
  • Centro Oftalmológico Dr. Charles S.A.
  • Oftalmos
  • Buenos Aires Mácula
  • Grupo Laser Vision
  • Organizacion Medica de Investigacion
  • The Retina Centre of Ottawa
  • Toronto Retina Institute
  • Institut De L'Oeil Des Laurentides
  • Rambam Medical Center; Opthalmology
  • Hadassah MC; Ophtalmology
  • Rabin MC; Ophtalmology
  • Kaplan Medical Center; Ophtalmology
  • Tel Aviv Sourasky MC; Ophtalmology
  • Pusan National University Hospital
  • Yeungnam University Medical Center
  • Seoul National University Bundang Hospital
  • Asan Medical Center
  • Kim's Eye Hospital
  • Samsung Medical Center
  • Centrum Medyczne Julianow
  • Dobry Wzrok Sp Z O O
  • Poradnia Okulistyczna i Salon Optyczny w Gliwicach- PRYZMAT
  • Uniwersyteckie Centrum Kliniczne; UCK im prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego
  • Centrum Medyczne UNO-MED
  • SPSK nr 1 w Lublinie; Klinika Chirurgii Siatkowki i Ciala Szklistego
  • Centrum Diagnostyki i Mikrochirurgii Oka LENS
  • LensClinic
  • Caminomed
  • Emanuelli Research and Development Center LLC
  • Clinica Universitaria de Navarra; Servicio de Oftalmologia
  • Clinica Universitaria de Navarra; Servicio de Oftalmologia
  • Hospital Universitario Miguel Servet; Servicio de Oftalmologia
  • Gloucestershire Hospitals NHS Foundation Trust
  • Royal Surrey County Hospital
  • Moorfields Eye Hospital NHS Foundation Trust
  • Kings College Hospital NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A: RO7200220 + Ranibizumab

Arm B: Ranibizumab

Arm Description

Participants will receive RO7200220, 1 milligram (mg) administered as intravitreal (IVT) injection in combination with ranibizumab, 0.5 mg IVT, on Day 1 and every fourth week (Q4W) up to Week 44, for a total of 12 injections, followed by an observational period up to Week 72.

Participants will receive ranibizumab, 0.5 mg IVT, from Day 1 and Q4W in combination with sham up to Week 44, for a total of 12 injections, followed by an observational period up to Week 72.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of Participants with Systemic and Ocular Adverse Events (AEs)
Number of Participants with Abnormal Laboratory Findings, Abnormal Vital Signs Values, or Abnormal Electrocardiogram (ECG) Parameters
Number of Participants with Abnormalities in Standard Ophthalmological Assessments
Mean Change From Baseline in BCVA Averaged Over Week 44 and Week 48, in Previously Treated Participants
Mean Change From Baseline in BCVA Averaged Over Week 44 and Week 48, in Overall Enrolled Population
Mean Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Treatment-naïve Participants
Mean Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Previously Treated Participants
Mean Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Overall Enrolled Population
Mean Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Treatment-naïve Participants
Mean Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Previously Treated Participants
Mean Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Overall Enrolled Population
Mean Change from Baseline in BCVA Over Time
Percentage of Participants Gaining ≥ 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA Over Time
Percentage of Participants Avoiding a Loss of ≥ 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA Over Time
Percentage of of Participants with BCVA ≥ 69 Letters (20/40 Snellen Equivalent) or ≥ 84 Letters (20/20 Snellen Equivalent) Over Time
Percentage of Participants with BCVA ≤38 Letters (20/200 Snellen Equivalent) Over Time
Change from Baseline in Central Subfield Thickness (CST) at Week 48
Change from Baseline in CST at Week 36
Change from Baseline in CST at Week 24
Mean Change from Baseline in CST Over Time
Percentage of Participants with Absence of Diabetic Macular Edema Over Time
Number of Participants with Absence of Intraretinal Fluid and/or Subretinal Fluid Over Time

Full Information

First Posted
December 8, 2021
Last Updated
August 16, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT05151744
Brief Title
A Study to Investigate RO7200220 in Combination With Ranibizumab in Diabetic Macular Edema
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 17, 2021 (Actual)
Primary Completion Date
March 19, 2024 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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 RO7200220 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
187 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A: RO7200220 + Ranibizumab
Arm Type
Experimental
Arm Description
Participants will receive RO7200220, 1 milligram (mg) administered as intravitreal (IVT) injection in combination with ranibizumab, 0.5 mg IVT, on Day 1 and every fourth week (Q4W) up to Week 44, for a total of 12 injections, followed by an observational period up to Week 72.
Arm Title
Arm B: Ranibizumab
Arm Type
Active Comparator
Arm Description
Participants will receive ranibizumab, 0.5 mg IVT, from Day 1 and Q4W in combination with sham up to Week 44, for a total of 12 injections, followed by an observational period up to Week 72.
Intervention Type
Drug
Intervention Name(s)
RO7200220
Intervention Description
RO7200220 will be administered by IVT injection in the study eye.
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
Ranibizumab will be administered by IVT injection in the study eye.
Intervention Type
Other
Intervention Name(s)
Sham Procedure
Intervention Description
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 Outcome Measure Information:
Title
Mean 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
Secondary Outcome Measure Information:
Title
Number of Participants with Systemic and Ocular Adverse Events (AEs)
Time Frame
Up to Week 72
Title
Number of Participants with Abnormal Laboratory Findings, Abnormal Vital Signs Values, or Abnormal Electrocardiogram (ECG) Parameters
Time Frame
Up to Week 72
Title
Number of Participants with Abnormalities in Standard Ophthalmological Assessments
Time Frame
Up to Week 72
Title
Mean Change From Baseline in BCVA Averaged Over Week 44 and Week 48, in Previously Treated Participants
Time Frame
Baseline, Week 44 and Week 48
Title
Mean Change From Baseline in BCVA Averaged Over Week 44 and Week 48, in Overall Enrolled Population
Time Frame
Baseline, Week 44 and Week 48
Title
Mean Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Treatment-naïve Participants
Time Frame
Baseline, Week 20 and Week 24
Title
Mean Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Previously Treated Participants
Time Frame
Baseline, Week 20 and Week 24
Title
Mean Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Overall Enrolled Population
Time Frame
Baseline, Week 20 and Week 24
Title
Mean Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Treatment-naïve Participants
Time Frame
Baseline, Week 32 and Week 36
Title
Mean Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Previously Treated Participants
Time Frame
Baseline, Week 32 and Week 36
Title
Mean Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Overall Enrolled Population
Time Frame
Baseline, Week 32 and Week 36
Title
Mean Change from Baseline in BCVA Over Time
Time Frame
From baseline to end of study (up to Week 72)
Title
Percentage of Participants Gaining ≥ 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA Over Time
Time Frame
From baseline to end of study (up to Week 72)
Title
Percentage of Participants Avoiding a Loss of ≥ 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA Over Time
Time Frame
From baseline to end of study (up to Week 72)
Title
Percentage of of Participants with BCVA ≥ 69 Letters (20/40 Snellen Equivalent) or ≥ 84 Letters (20/20 Snellen Equivalent) Over Time
Time Frame
From baseline to end of study (up to Week 72)
Title
Percentage of Participants with BCVA ≤38 Letters (20/200 Snellen Equivalent) Over Time
Time Frame
From baseline to end of study (up to Week 72)
Title
Change from Baseline in Central Subfield Thickness (CST) at Week 48
Time Frame
Baseline, Week 48
Title
Change from Baseline in CST at Week 36
Time Frame
Baseline, Week 36
Title
Change from Baseline in CST at Week 24
Time Frame
Baseline, Week 24
Title
Mean Change from Baseline in CST Over Time
Time Frame
From baseline to end of study (up to Week 72)
Title
Percentage of Participants with Absence of Diabetic Macular Edema Over Time
Time Frame
From baseline to end of study (up to Week 72)
Title
Number of Participants with Absence of Intraretinal Fluid and/or Subretinal Fluid Over Time
Time Frame
From baseline to end of study (up to Week 72)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Win Retina
City
Arcadia
State/Province
California
ZIP/Postal Code
91006
Country
United States
Facility Name
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Bay Area Retina Associates
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Florida Eye Associates
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
Retina Vitreous Associates of Florida
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33711-1141
Country
United States
Facility Name
Cumberland Valley Retina Consultants
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740-5940
Country
United States
Facility Name
Deep Blue Retina PLLC
City
Southaven
State/Province
Mississippi
ZIP/Postal Code
38671
Country
United States
Facility Name
Verum Research LLC
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Texas Retina Associates
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Retina Consultants of Texas
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77384-4167
Country
United States
Facility Name
Rocky Mountain Retina
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Centro Oftalmológico Dr. Charles S.A.
City
Capital Federal
ZIP/Postal Code
C1015ABO
Country
Argentina
Facility Name
Oftalmos
City
Capital Federal
ZIP/Postal Code
C1120AAN
Country
Argentina
Facility Name
Buenos Aires Mácula
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1061AAE
Country
Argentina
Facility Name
Grupo Laser Vision
City
Rosario
ZIP/Postal Code
S2000DLA
Country
Argentina
Facility Name
Organizacion Medica de Investigacion
City
San Nicolás
ZIP/Postal Code
C1015ABO
Country
Argentina
Facility Name
The Retina Centre of Ottawa
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K2B 7E9
Country
Canada
Facility Name
Toronto Retina Institute
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3C 0G9
Country
Canada
Facility Name
Institut De L'Oeil Des Laurentides
City
Boisbriand
State/Province
Quebec
ZIP/Postal Code
J7H 0E8
Country
Canada
Facility Name
Rambam Medical Center; Opthalmology
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Hadassah MC; Ophtalmology
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Rabin MC; Ophtalmology
City
Petach Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Kaplan Medical Center; Ophtalmology
City
Rehovot
ZIP/Postal Code
7660101
Country
Israel
Facility Name
Tel Aviv Sourasky MC; Ophtalmology
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Pusan National University Hospital
City
Busan
ZIP/Postal Code
602-739
Country
Korea, Republic of
Facility Name
Yeungnam University Medical Center
City
Daegu
ZIP/Postal Code
42415
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Kim's Eye Hospital
City
Seoul
ZIP/Postal Code
07301
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Centrum Medyczne Julianow
City
?ód?
ZIP/Postal Code
91-321
Country
Poland
Facility Name
Dobry Wzrok Sp Z O O
City
Gda?sk
ZIP/Postal Code
80-402
Country
Poland
Facility Name
Poradnia Okulistyczna i Salon Optyczny w Gliwicach- PRYZMAT
City
Gliwice
ZIP/Postal Code
44-100
Country
Poland
Facility Name
Uniwersyteckie Centrum Kliniczne; UCK im prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego
City
Katowice
ZIP/Postal Code
40-514
Country
Poland
Facility Name
Centrum Medyczne UNO-MED
City
Krakow
ZIP/Postal Code
31-070
Country
Poland
Facility Name
SPSK nr 1 w Lublinie; Klinika Chirurgii Siatkowki i Ciala Szklistego
City
Lublin
ZIP/Postal Code
20-079
Country
Poland
Facility Name
Centrum Diagnostyki i Mikrochirurgii Oka LENS
City
Olsztyn
ZIP/Postal Code
10-424
Country
Poland
Facility Name
LensClinic
City
Rybnik
ZIP/Postal Code
44-203
Country
Poland
Facility Name
Caminomed
City
Tarnowskie Góry
ZIP/Postal Code
42-600
Country
Poland
Facility Name
Emanuelli Research and Development Center LLC
City
Arecibo
ZIP/Postal Code
00612
Country
Puerto Rico
Facility Name
Clinica Universitaria de Navarra; Servicio de Oftalmologia
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Clinica Universitaria de Navarra; Servicio de Oftalmologia
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Facility Name
Hospital Universitario Miguel Servet; Servicio de Oftalmologia
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Gloucestershire Hospitals NHS Foundation Trust
City
Gloucestershire
ZIP/Postal Code
GL1 3NN
Country
United Kingdom
Facility Name
Royal Surrey County Hospital
City
Guildford
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
Facility Name
Moorfields Eye Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
EC1V 2PD
Country
United Kingdom
Facility Name
Kings College Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org/). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm)

Learn more about this trial

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

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