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

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05151744
• Collaborator: (none)
• Enrollment: 230
• Locations: 30
• Arms: 2
• Anticipated Duration (Months): 24.9
• Patients Per Site: 7.7
• Patients Per Site Per Month: 0.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Macular Edema	Drug: RO7200220; Drug: Ranibizumab; Other: Sham Procedure	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 230 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 in Combination With Ranibizumab Administered Intravitreally in Patients With Diabetic Macular Edema
• Actual Study Start Date: Dec 17, 2021
• Anticipated Primary Completion Date: Jan 15, 2024
• Anticipated Study Completion Date: Jan 15, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A: RO7200220 + Ranibizumab 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.	Drug: RO7200220; RO7200220 will be administered by IVT injection in the study eye.; Drug: Ranibizumab; Ranibizumab will be administered by IVT injection in the study eye.; Other Names: Lucentis
Active Comparator: Arm B: Ranibizumab 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.	Drug: Ranibizumab; Ranibizumab will be administered by IVT injection in the study eye.; Other Names: Lucentis ; 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.

Outcome Measures

Primary Outcome Measures

1. Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Averaged Over Week 44 and Week 48, in Treatmentnaïve 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. Mean Change from Baseline in BCVA Over Time [From baseline to end of study (up to Week 72)]

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

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

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

16. Percentage of Participants with BCVA ≤38 Letters (20/200 Snellen Equivalent) Over Time [From baseline 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. Mean Change from Baseline in CST Over Time [From baseline to end of study (up to Week 72)]

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

22. Number of Participants with Absence of Intraretinal Fluid and/or Subretinal Fluid Over Time [From baseline 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	Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center	Torrance	California	United States	90502
3	Bay Area Retina Associates	Walnut Creek	California	United States	94598
4	Florida Eye Associates	Melbourne	Florida	United States	32901
5	Cumberland Valley Retina Consultants	Hagerstown	Maryland	United States	21740
6	Deep Blue Retina PLLC	Southaven	Mississippi	United States	38671
7	Verum Research LLC	Eugene	Oregon	United States	97401
8	Texas Retina Associates	Arlington	Texas	United States	76012
9	Retina Consultants of Texas	Bellaire	Texas	United States	77401
10	Rocky Mountain Retina	Salt Lake City	Utah	United States	84107
11	Organizacion Medica de Investigacion	Buenos Aires		Argentina	C1015ABO
12	Centro Oftalmológico Dr. Charles S.A.	Capital Federal		Argentina	C1015ABO
13	Oftalmos	Capital Federal		Argentina	C1120AAN
14	Buenos Aires Mácula	Ciudad Autonoma Buenos Aires		Argentina	C1061AAE
15	The Retina Centre of Ottawa	Ottawa	Ontario	Canada	K2B 7E9
16	Toronto Retina Institute	Toronto	Ontario	Canada	M3C 0G9
17	Rambam Medical Center; Opthalmology	Haifa		Israel	3109601
18	Hadassah MC; Ophtalmology	Jerusalem		Israel	9112001
19	Rabin MC; Ophtalmology	Petach Tikva		Israel	4941492
20	Kaplan Medical Center; Ophtalmology	Rehovot		Israel	7660101
21	Tel Aviv Sourasky MC; Ophtalmology	Tel Aviv		Israel	6423906
22	Centrum Medyczne UNO-MED	Krakow		Poland	31-070
23	Centrum Diagnostyki i Mikrochirurgii Oka LENS	Olsztyn		Poland	10-424
24	Emanuelli Research and Development Center LLC	Arecibo		Puerto Rico	00612
25	Hospital Universitario Miguel Servet; Servicio de Oftalmologia	Zaragoza		Spain	50009
26	Bradford Royal Infirmary	Bradford		United Kingdom	BD9 6RJ
27	Gloucestershire Hospitals NHS Foundation Trust	Gloucestershire		United Kingdom	GL1 3NN
28	Royal Surrey County Hospital	Guildford		United Kingdom	GU2 7XX
29	Moorfields Eye Hospital NHS Foundation Trust	London		United Kingdom	EC1V 2PD
30	Kings College Hospital NHS Foundation Trust	London		United Kingdom	SE5 9RS

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: NCT05151744
• Other Study ID Numbers: BP43464; 2021-004390-31
• First Posted: Dec 9, 2021
• Last Update Posted: Aug 22, 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 22, 2022