Clinical trial NCT06771271: A Study to Investigate RO7200220 as Monotherapy and in Combination With Ranibizumab in Participants With Diabetic and Uveitic Macular Edema
Official title: A Multi-center, Non-Randomized, Open-label, Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7200220 in Monotherapy and in Combination With Ranibizumab Following Intravitreal Administration in Patients With Diabetic or Uveitic Macular Edema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetic Macular Edema
Uveitic Macular Edema
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2025-01-13
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

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).

Exclusion Criteria:

* 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

Primary outcomes:
measure: Part 1: Number of Participants With Adverse Events (AEs)
timeFrame: Up to 18 weeks
measure: Part 2: Number of Participants With Adverse Events (AEs)
timeFrame: Up to 24 weeks
measure: Part 3: Number of Participants With Adverse Events (AEs)
timeFrame: Up to 20 weeks
measure: Part 4: Number of Participants With Adverse Events (AEs)
timeFrame: Up to 36 weeks
Secondary outcomes:
measure: Maximum Serum Concentration (Cmax)
timeFrame: Part 1: Up to Week 18; Parts 2: Up to Week 24; Part 3: Up to Week 20; Part 4: Up to Week 36
measure: Minimum Serum Concentration (Ctrough)
timeFrame: Part 1: Up to Week 18; Parts 2: Up to Week 24; Part 3: Up to Week 20; Part 4: Up to Week 36
measure: Time to Peak Serum Concentration (Tmax)
timeFrame: Part 1: Up to Week 18; Parts 2: Up to Week 24; Part 3: Up to Week 20; Part 4: Up to Week 36
measure: Area Under the Concentration-time Curve to the End of Dosing Period (AUC0-t)
timeFrame: Part 1: Up to Week 18; Parts 2: Up to Week 24; Part 3: Up to Week 20; Part 4: Up to Week 36
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Retina-Vitreous Associates Medical Group
state: California
city: Oxnard
country: United States
facility: California Retina Consultants
state: California
city: Palm Desert
country: United States
facility: Retina Institute of California Medical Group d/b/a Acuity Eye Group
state: California
city: Palo Alto
country: United States
facility: Byers Eye Insitute at Stanford
state: California
city: Melbourne
country: United States
facility: Florida Eye Associates
state: Florida
city: Saint Petersburg
country: United States
facility: Retina Vitreous Assoc of FL
state: Florida
city: Oak Park
country: United States
facility: Illinois Retina Associates SC
state: Illinois
city: Hagerstown
country: United States
facility: Cumberland Valley Retina PC
state: Maryland
city: Reno
country: United States
facility: Sierra Eye Associates
state: Nevada
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Portland
country: United States
facility: Oregon HSU
state: Oregon
city: Philadelphia
country: United States
facility: Mid Atlantic Retina
state: Pennsylvania
city: Abilene
country: United States
facility: Retina Res Institute of Texas
state: Texas
city: Austin
country: United States
facility: Austin Clinical Research LLC
state: Texas
city: McAllen
country: United States
facility: Valley Retina Institute P.A.
state: Texas
city: San Antonio
country: United States
facility: Medical Center Ophthalmology Associates
state: Texas
city: Charlottesville
country: United States
facility: Univ of Virginia Ophthalmology
state: Virginia
city: Seattle
country: United States
facility: Karalis Johnson Retina Center
state: Washington
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: