This study is designed to assess the safety and initial evidence of efficacy of the novel compound SOM-401 (K8), a derivative of a nucleoside reverse transcriptase inhibitor, in subjects with untreated, clinically significant, diabetic macular edema (DME).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
Subjects will have the treatment administered intravitreally (one eye only) using an injector system on a 24-gauge needle to deliver a cylindrical, 3 mm long, drug eluting pellet containing 300 µg of K8. Participants will be followed for 168 days (24 weeks).
University of Kentucky
Lexington, Kentucky, United States
Mean change in central subfield thickness
Central subfield thickness (CST) measured on spectral domain-optical coherence tomography (SD-OCT)
Time frame: At week 4 (change as measured from baseline)
Mean change in best-corrected visual acuity (BCVA)
best-corrected visual acuity as defined by the number of letters read on the scale set by the ETDRS (Early Treatment of Diabetic Retinopathy Study). (More letters read equates to better visual acuity)
Time frame: At week 4 (change as measured from baseline)
Adverse Events
Frequency of participants experiencing ocular or systemic adverse events.
Time frame: Within the study period (of 24 weeks)
Resolution of macular edema
Frequency of participants experiencing resolution of macular edema
Time frame: 24 weeks (at 2, 4, 8, 12, 16, and 24 weeks)
Clinically significant change in visual acuity
Frequency of participants experiencing clinically significant change.
Time frame: 24 weeks (at 2, 4, 8, 12, 16, and 24 weeks)
Change in score on the ETDRS Multi-Step Scale of Diabetic Retinopathy
The Early Treatment Diabetic Retinopathy Study (ETDRS DRSS) was developed to categorize the severity of diabetic retinopathy based on several fundus photographic characteristics. There are 13 levels in the original ETDRS scale, and a severity step or level increase is associated with an increased risk of retinopathy progression. The scale goes from 10 to 85, with higher scores being worse.
Time frame: 24 weeks
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Visual acuity
The proportion of subjects who have an change from baseline of ETDRS letters read of ≥ 5 letters, ≥ 10 letters or ≥ 15 letters of visual acuity.
Time frame: 24 weeks (at 2, 4, 8, 12, 16, and 24 weeks)
Change in retinal thickening
Total area in disc diameters of retinal thickening of the lesion involving the foveal center, based on fundus imaging.
Time frame: 24 weeks (at 2, 4, 8, 12, 16, and 24 weeks)
Change in hard exudates
Total area in disc diameters of hard exudates in the lesion involving the macula, based on fundus imaging.
Time frame: 24 weeks (at 2, 4, 8, 12, 16, and 24 weeks)
Change in foveal avascular zone.
Foveal avascular zone size as determined using OCT-Angiography
Time frame: 24 weeks (at 2, 4, 8, 12, 16, and 24 weeks)
Proportion of subjects requiring rescue treatment
Proportion of subjects requiring rescue treatment
Time frame: 24 weeks (at 2, 4, 8, 12, 16, and 24 weeks)
Proportion of subjects requiring vitrectomy
Proportion of subjects requiring vitrectomy
Time frame: 24 weeks (at 2, 4, 8, 12, 16, and 24 weeks)
Mean change in central subfield thickness at other study timepoints
Central subfield thickness (CST) measured on spectral domain-optical coherence tomography (SD-OCT)
Time frame: 24 weeks (at 2, 8, 12, 16, and 24 weeks)
Mean change in best-corrected visual acuity (BCVA) at other study timepoints
best-corrected visual acuity as defined by the number of letters read on the scale set by the ETDRS (Early Treatment of Diabetic Retinopathy Study). (More letters read equates to better visual acuity)
Time frame: 24 weeks (at 2, 4, 8, 12, 16, and 24 weeks)