Phase 2

In 2018, Kato Pharmaceuticals will be conducting a 100 patient Phase 2 multicenter, randomized trial of the safety and treatment benefit of single and repeat administration of Resolv ER. The objective is to assess the safety of intravitreal administration of Resolv ER and the capability of the treatment to produce a complete posterior vitreous detachment (PVD) in patients with mild to moderate non-proliferative diabetic retinopathy (NPDR).

The progression of NPDR to proliferative diabetic retinopathy tends to be less severe in subjects with a total PVD. A total PVD is defined as a posterior vitreous detachment from the periphery beyond the macula to the periphery beyond the optic disk, as assessed by wide-field optical coherence tomography (WF-OCT). Total PVD eliminates the nutrient scaffold between the hyaloid membrane and the retina interface. As a result, neovascularization and diabetic retinopathy is inhibited.

A prior study reported success with non-liposome loaded formulation, for intravitreal injection for the inducement of PVD in patients with NPDR. Phase 1 through Phase 3 human clinical trials were conducted in the U.S., Mexico, India and Armenia before discontinuing the program. No treatment related serious adverse effects in any of these trials (n=210). The patient population were confirmed diabetics with NPDR. The trial demonstrated safety and efficacy of the urea formulation on relaxing the bonds between the vitreous and the retina and thus inducing a PVD.

Wide Field SD-OCT: Structural abnormalities in diabetic retinopathy can be detected and characterized by spectral domain-OCT. SD-OCT complements Fluorescein Angiography in understanding the pathology and managing it accordingly. SD-OCT brings new insights into morphological changes of the retina in DR. It enhances the ability to exactly identify the epiretinal membranes (ERM), vitreomacular traction (VMT) and the posterior hyaloid status.

CRO: TrialRunners

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