A Study to Investigate RO7200220 as Monotherapy and in Combination With Ranibizumab in Participants With Diabetic and Uveitic Macular Edema
- Conditions
- Diabetic Macular EdemaUveitic Macular Edema
- Interventions
- Registration Number
- NCT06771271
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
The purpose of this study was to assess the safety and tolerability of RO7200220 as monotherapy (diabetic macular edema \[DME\] or uveitic macular edema \[UME\] population) and in combination with ranibizumab (DME population only).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 85
DME Participants:
- Diagnosis of Diabetes Mellitus (DM) (Type 1 or Type 2), as defined by the World Health Organization and/or American Diabetes Association
- Macular edema associated with DR defined as macular thickening by spectral domain optical coherence tomography (SD-OCT) involving the center of the macula: central subfield thickness (CST) of ≥325 μm with Spectralis.
- Decreased visual acuity (VA) attributable primarily to DME, with BCVA letter score of 73 to 19 letters (both inclusive) on Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts (20/40 -20/400 Snellen equivalent).
- Clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images to confirm diagnosis.
UME Participants:
- Diagnosis of noninfectious uveitis (NIU) of any anatomical type (anterior, intermediate, posterior, panuveitis). Active and inactive NIU is allowed.
- Macular edema associated with NIU defined as macular thickening by SD-OCT involving the center of the macula: CST of ≥325 μm with Spectralis.
- Decreased VA attributable primarily to UME, with BCVA letter score of 78 to 19 letters (both inclusive) on ETDRS-like charts (20/32 - 20/400 Snellen equivalent).
- Sufficiently clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images to confirm diagnosis.
- Either treatment naive or previously treated in the study eye or systematically (with washout periods and maximum doses applicable for specific treatments).
- Any major illness or major surgical procedure within 1 month prior to Day 1
- Any febrile illness within 1 week prior to screening or Day 1
- Any stroke or myocardial infarction within 12 months prior to Day 1
- Any active proliferative DR (DME participants only)
- Panretinal photocoagulation or macular laser photocoagulation treatment prior to Day 1
- History of vitreoretinal surgery/pars plana vitrectomy
- Any cataract surgery within 3 months prior to Day 1 or any planned surgery during the study
- History of any glaucoma surgery including laser glaucoma procedures
- Uncontrolled glaucoma
- History of rubeosis iridis
- Any active ocular or periocular infection on Day 1
- Any presence of active intraocular inflammation on Day 1 or any history of intraocular inflammation (DME participants only)
- Any prior or concomitant periocular or IVT corticosteroids in the study eye (DME treatment naive participants only)
- Use of any systemic corticosteroids within 1 month prior to Day 1 (stable oral prednisone for UME participants allowed)
- Any prior or concomitant systemic anti-VEGF treatment within 6 months prior to Day 1
- Any concurrent use of biologics for immune-related diseases
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 1: RO7200220 Monotherapy RO7200220 Participants with DME received multiple ascending doses of RO7200220 (two doses at the assigned dose level), as intravitreal (IVT) injection, every 6 weeks (Q6W) in multiple cohorts. Part 2: Expansion of RO7200220 Monotherapy RO7200220 Participants with DME who were anti-VEGF and corticosteroid IVT treatment-naive received three doses of RO7200220 monotherapy, as IVT injection, every 4 weeks (Q4W) in Part 2 cohorts. Part 3: RO7200220 in Combination with Ranibizumab RO7200220 Participants with DME received RO7200220 as IVT injection followed by ranibizumab, 0.5 milligrams (mg) as IVT injection in Part 3. Part 3: RO7200220 in Combination with Ranibizumab Ranibizumab Participants with DME received RO7200220 as IVT injection followed by ranibizumab, 0.5 milligrams (mg) as IVT injection in Part 3. Part 4: RO7200220 Monotherapy RO7200220 Participants with UME received multiple doses of RO7200220 (three doses at the assigned dose level), as IVT injection, Q4W in multiple cohorts.
- Primary Outcome Measures
Name Time Method Part 1: Number of Participants With Adverse Events (AEs) Up to 18 weeks Part 2: Number of Participants With Adverse Events (AEs) Up to 24 weeks Part 3: Number of Participants With Adverse Events (AEs) Up to 20 weeks Part 4: Number of Participants With Adverse Events (AEs) Up to 36 weeks
- Secondary Outcome Measures
Name Time Method Area Under the Concentration-time Curve to the End of Dosing Period (AUC0-t) Part 1: Up to Week 18; Parts 2: Up to Week 24; Part 3: Up to Week 20; Part 4: Up to Week 36 Time to Peak Serum Concentration (Tmax) Part 1: Up to Week 18; Parts 2: Up to Week 24; Part 3: Up to Week 20; Part 4: Up to Week 36 Maximum Serum Concentration (Cmax) Part 1: Up to Week 18; Parts 2: Up to Week 24; Part 3: Up to Week 20; Part 4: Up to Week 36 Minimum Serum Concentration (Ctrough) Part 1: Up to Week 18; Parts 2: Up to Week 24; Part 3: Up to Week 20; Part 4: Up to Week 36
Related Research Topics
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Trial Locations
- Locations (19)
Retina-Vitreous Associates Medical Group
🇺🇸Beverly Hills, California, United States
Retina Institute of California Medical Group d/b/a Acuity Eye Group
🇺🇸Palm Desert, California, United States
Byers Eye Insitute at Stanford
🇺🇸Palo Alto, California, United States
Florida Eye Associates
🇺🇸Melbourne, Florida, United States
Retina Vitreous Assoc of FL
🇺🇸Saint Petersburg, Florida, United States
Illinois Retina Associates SC
🇺🇸Oak Park, Illinois, United States
Cumberland Valley Retina PC
🇺🇸Hagerstown, Maryland, United States
Sierra Eye Associates
🇺🇸Reno, Nevada, United States
Wake Forest Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Oregon HSU
🇺🇸Portland, Oregon, United States
California Retina Consultants
🇺🇸Oxnard, California, United States
Mid Atlantic Retina
🇺🇸Philadelphia, Pennsylvania, United States
Retina Res Institute of Texas
🇺🇸Abilene, Texas, United States
Austin Clinical Research LLC
🇺🇸Austin, Texas, United States
Valley Retina Institute P.A.
🇺🇸McAllen, Texas, United States
Medical Center Ophthalmology Associates
🇺🇸San Antonio, Texas, United States
Univ of Virginia Ophthalmology
🇺🇸Charlottesville, Virginia, United States
Karalis Johnson Retina Center
🇺🇸Seattle, Washington, United States