A Phase 1 interventional study of OTX-TKI and Sham in Non-proliferative Diabetic Retinopathy, sponsored by Ocular Therapeutix, Inc.. Active, not recruiting at 10 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-08.
Sponsored by Ocular Therapeutix, Inc. · Phase 1, Interventional, and Treatment
Evaluate the Safety, Tolerability, and Efficacy of OTX-TKI in Subjects with Moderately Severe to Severe Non-proliferative Diabetic Retinopathy
Multicenter, Double-Masked, Randomized, Parallel Group Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-TKI (axitinib implant) for Intravitreal Injection in Subjects with Moderately Severe to Severe Non-proliferative Diabetic Retinopathy
815 studies on the registry are indexed under Retinal Diseases; 105 are open to participants now.
This study's planned enrollment of 21 is below the median of 60 across 500 interventional studies indexed under Retinal Diseases.
Browse Retinal Diseases studies →Ocular Therapeutix, Inc. is the lead sponsor of 32 studies on the registry; 2 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 6 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: OTX-TKI
Drug: Sham
Injection of OTX-TKI
Sham Injection of OTX-TKI
Safety and Tolerability
Frequency of treatment emergent adverse events
Time frame: Baseline up to Week 52
Change in Best Corrected Visual Acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score
Best Corrected Visual Acuity (BCVA) changes from baseline
Time frame: Baseline up to Week 52
Central subfield thickness changes
Central subfield thickness changes from baseline
Time frame: Baseline up to Week 52
Rescue Therapy
Proportion of subjects receiving rescue therapy
Time frame: Baseline up to Week 52
Diabetic Retinopathy Severity Scale (DRSS) changes
Diabetic Retinopathy Severity Scale (DRSS) changes from baseline
Time frame: Baseline up to Week 52
Plan to share: Undecided
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Ocular Therapeutix, Inc.