Clinical trial NCT05699759: Safety and Effect of Intravitreal Injection of a Derivative of Nucleoside Reverse Transcriptase Inhibitor in Subjects with Diabetic Macular Edema
Official title: A Non-randomized, Open Label, Safety and Efficacy Study Evaluating a Single Dose of Kamuvudine-8 (K8) for the Treatment of Patients with Diabetic Macular Edema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetic Macular Edema
Keywords: diabetes
kamuvudine
K8
SOM-401
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: Inflammasome Therapeutics
First posted: 2023-01-26
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* BCVA of ≥ 24 and ≤ 73 letters (20/40 or worse but at least 20/320) by an ETDRS chart. BCVA of the non-study eye must be no worse than 20/400)
* Diagnosis of diabetes mellitus, type 1 or 2 with non-proliferative or non-high risk proliferative diabetic retinopathy.
* DME based on investigator's clinical evaluation and demonstrated on fundus photographs, fluorescein angiograms, and spectral domain-optical coherence tomography (SD-OCT)
* Mean foveal thickness of at least 300 µm by SD-OCT
* Ability and willingness to comply with the treatment and follow-up procedures
* Ability to understand and sign the informed consent form
* Intraocular pressure of ≤ 21 on 2 or less IOP lowering medications

Exclusion Criteria:

* Pregnant patients, currently lactating patients, or females of childbearing potential (unless using reliable contraception such as double barrier, surgical sterilization, oral contraceptives, intrauterine device (IUD), etc.)
* Allergy or hypersensitivity (known or suspected) to fluorescein or any component of the investigational product or delivery system
* Any ocular surgery in the study eye within 12 weeks of screening
* Any history of vitrectomy in the study eye
* Aphakia in the study eye
* Presence of severe foveal ischemia, defined as foveal avascular zone (FAZ) of \>1.5 mm2 on OCT-Angiography
* Prior intraocular or periocular treatment for DME
* Macular laser for the treatment of diabetic macular edema within 12 weeks of screening
* Any change in systemic steroidal therapy within 3 months of screening
* Retinal or choroidal neovascularization due to ocular conditions other than diabetic retinopathy
* History or presence of viral disease of the cornea or conjunctiva
* History or presence of any disease or condition that in the investigator's opinion would preclude study treatment or follow-up or that in the opinion of the investigator would render them as unlikely to benefit from study treatment.
* Any lens or corneal opacity which impairs visualization of the posterior pole
* Participation in another clinical trial within 12 weeks before the screening visit or during the study
* Expectation that subject will be moving away from the area of the clinical treatment center without the ability to return for visits within the study period

Primary outcomes:
measure: Mean change in central subfield thickness
timeFrame: At week 4 (change as measured from baseline)
measure: Mean change in best-corrected visual acuity (BCVA)
timeFrame: At week 4 (change as measured from baseline)
measure: Adverse Events
timeFrame: Within the study period (of 24 weeks)
Secondary outcomes:
measure: Resolution of macular edema
timeFrame: 24 weeks (at 2, 4, 8, 12, 16, and 24 weeks)
measure: Clinically significant change in visual acuity
timeFrame: 24 weeks (at 2, 4, 8, 12, 16, and 24 weeks)
measure: Change in score on the ETDRS Multi-Step Scale of Diabetic Retinopathy
timeFrame: 24 weeks
measure: Visual acuity
timeFrame: 24 weeks (at 2, 4, 8, 12, 16, and 24 weeks)
measure: Change in retinal thickening
timeFrame: 24 weeks (at 2, 4, 8, 12, 16, and 24 weeks)
measure: Change in hard exudates
timeFrame: 24 weeks (at 2, 4, 8, 12, 16, and 24 weeks)
measure: Change in foveal avascular zone.
timeFrame: 24 weeks (at 2, 4, 8, 12, 16, and 24 weeks)
measure: Proportion of subjects requiring rescue treatment
timeFrame: 24 weeks (at 2, 4, 8, 12, 16, and 24 weeks)
measure: Proportion of subjects requiring vitrectomy
timeFrame: 24 weeks (at 2, 4, 8, 12, 16, and 24 weeks)
measure: Mean change in central subfield thickness at other study timepoints
timeFrame: 24 weeks (at 2, 8, 12, 16, and 24 weeks)
measure: Mean change in best-corrected visual acuity (BCVA) at other study timepoints
timeFrame: 24 weeks (at 2, 4, 8, 12, 16, and 24 weeks)
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Michelle Abou-Jaoude, MD
role: PRINCIPAL_INVESTIGATOR
References: