A Study to Investigate RO7200220 as Monotherapy and in Combination With Ranibizumab in Participan… (NCT06771271) | Clinical Trial Compass
CompletedPhase 1
A Study to Investigate RO7200220 as Monotherapy and in Combination With Ranibizumab in Participants With Diabetic and Uveitic Macular Edema
United States85 participantsStarted 2019-07-22
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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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…
What they're measuring
1
Part 1: Number of Participants With Adverse Events (AEs)
Timeframe: Up to 18 weeks
2
Part 2: Number of Participants With Adverse Events (AEs)
Timeframe: Up to 24 weeks
3
Part 3: Number of Participants With Adverse Events (AEs)
Timeframe: Up to 20 weeks
4
Part 4: Number of Participants With Adverse Events (AEs)