Exploratory Study to Investigate the Bioactivity, Ocular and Systemic Safety, Tolerability, and P… (NCT03790852) | Clinical Trial Compass
TerminatedPhase 1
Exploratory Study to Investigate the Bioactivity, Ocular and Systemic Safety, Tolerability, and Pharmacokinetics Following Single and Multiple Intravitreal Administrations of KSI-301 in Subjects With wAMD, DME and RVO
Stopped: All patients past planned primary endpoint; decision by Sponsor to wind down open-label follow-up activities.
United States121 participantsStarted 2018-12-26
Plain-language summary
This is a Phase 1b open-label study to assess the bioactivity, ocular and systemic safety, tolerability, and pharmacokinetics of repeated injections of KSI-301 at two dose levels: 2.5 mg and 5 mg
Who can participate
Age range21 Years
SexALL
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Inclusion criteria
✓. Treatment naïve wet age-related macular degeneration involving the fovea.
✓. A lesion area \<30 mm2 (12 disc areas) of any lesion type.
✓. BCVA ETDRS letter score ≤ 78 and ≥ 23 (-20/25 to -20/320 Snellen equivalent) in the study eye.
✓. Decrease in vision in the study eye determined by the investigator to be primarily the result of wAMD.
✓. Treatment naïve diabetic macular edema.
✓. BCVA ETDRS letter score ≤ 78 and ≥ 23 (-20/25 to -20/320 Snellen equivalent) in the study eye.
✓. Central subfield thickness (CST) of ≥ 300 microns on SD-OCT (Heidelberg Spectralis or equivalent).
✓. Decrease in vision in the study eye determined by the investigator to be primarily the result of DME.
Exclusion criteria
✕. Choroidal neovascularization due to causes other than age-related macular degeneration in the study eye.
What they're measuring
1
Incidence of ocular (study eye) and systemic adverse events
. Geographic atrophy and/or subretinal fibrosis involving the fovea of the study eye.
✕. Prior intravitreal anti-VEGF therapy in the study eye.
✕. Initial diagnosis of DME of more than 6 months from screening in the study eye.
✕. Hard exudates in the fovea.
✕. Prior intravitreal anti-VEGF therapy or steroid injection, or steroid implant (dexamethasone or triamcinolone) in the study eye.
✕. Moderate or dense vitreous hemorrhage preventing clear. visualization of the macula or optic disc in the study eye.
✕. Fibrovascular proliferation or tractional retinal detachment in the posterior pole in the study eye. If traction is present outside the posterior pole, it should be considered not at risk of increasing and threatening the macula with the use of anti-VEGF injections, in the investigator's judgement.