A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 in Non-proliferative Diabetic… (NCT05066230) | Clinical Trial Compass
TerminatedPhase 3
A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 in Non-proliferative Diabetic Retinopathy (NPDR)
Stopped: All patients completed the primary endpoint assessments. Additional follow-up after the primary endpoint was deemed not necessary by the Sponsor.
United States253 participantsStarted 2021-09-07
Plain-language summary
This Phase 3 Study will evaluate the efficacy and safety of KSI-301 in participants with moderately severe to severe non-proliferative diabetic retinopathy (NPDR).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Signed informed consent prior to participation in the study.
* Type 1 or 2 diabetes mellitus
* Moderately severe to severe NPDR in the Study Eye (DRSS levels 47 and 53 as determined by the reading center), in which pan-retinal photocoagulation (PRP) can be safely deferred for at least 6 months per the Investigator.
* BCVA ETDRS letter score in the Study Eye of ≥69 letters (approximate Snellen equivalent of 20/40 or better)
* HbA1c of ≤12%.
* Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
* Presence of center-involved DME in the Study Eye
* Prior PRP in the Study Eye.
* Current anterior segment neovascularization (ASNV), vitreous hemorrhage, or tractional retinal detachment in the Study Eye.
* Prior intravitreal anti-VEGF treatment in the Study Eye for DR or DME.
* Prior intravitreal or periocular steroid in the Study Eye for DR or DME.
* Prior use of an investigational intravitreal treatment for DR or DME in the Study Eye.
* Any history or evidence of a concurrent ocular condition present in the Study Eye, that in the opinion of the Investigator could require either medical or surgical intervention or alter visual acuity during the study
* Active or suspected ocular or periocular infection or inflammation.
* Women who are pregnant or lactating or intending to become pregnant during the study.
* History of a medical condition that, in the judgment of the Investigator, would preclude scheduled study visits, completion of the …
What they're measuring
1
Percentage of Patients Improving ≥2 Steps on DRSS