A Study to Investigate RO7200220 as Monotherapy and in Combination With Ranibizumab in Participants With Diabetic and Uveitic Macular Edema (DOVETAIL)
Status and phase
Completed
Phase 1
Conditions
Diabetic Macular Edema
Uveitic Macular Edema
Treatments
Drug: RO7200220
Drug: Ranibizumab
Details and patient eligibility
About
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).
Enrollment
85 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Non-Randomized
Interventional model
Sequential Assignment
Masking
None (Open label)
85 participants in 4 patient groups
Part 1: RO7200220 Monotherapy
Experimental group
Description:
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.
Treatment:
Drug: RO7200220
Part 2: Expansion of RO7200220 Monotherapy
Experimental group
Description:
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.
Treatment:
Drug: RO7200220
Part 3: RO7200220 in Combination with Ranibizumab
Experimental group
Description:
Participants with DME received RO7200220 as IVT injection followed by ranibizumab, 0.5 milligrams (mg) as IVT injection in Part 3.
Treatment:
Drug: Ranibizumab
Drug: RO7200220
Part 4: RO7200220 Monotherapy
Experimental group
Description:
Participants with UME received multiple doses of RO7200220 (three doses at the assigned dose level), as IVT injection, Q4W in multiple cohorts.
Treatment:
Drug: RO7200220
Trial contacts and locations
19
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Data sourced from clinicaltrials.gov
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