Safety and Effect of Intravitreal Delivery of Zidovudine Derivative, K8, in Subjects With Diabetic Macular Edema

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to assess the safety and initial evidence of efficacy of the novel compound K8, a zidovudine (AZT) derivative, in subjects with untreated, clinically significant, diabetic macular edema (DME).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Michelle Abou-Jaoude
• Collaborator: Inflammasome Therapeutics
• Treatments: Zidovudine

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