Safety and Efficacy Study of Topical Administration of FOV2304 (High Dose or Low Dose) for the Treatment of Center-involving Clinically Significant Macular Edema Associated With Diabetic Retinopathy

Study Overview
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Brief Summary
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The purpose of the study is to determine whether concentrations of FOV2304 (high dose or low dose) administered in the eye are more effective than placebo in treating patients with diabetic macular edema, following 12 weeks of treatment.

Official Title
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A 6-month, Phase II, Double-masked, Multicenter, Randomized, Placebo Controlled, Parallel Group Study to Assess the Safety and Efficacy of Topical Administration of Two Concentrations of FOV2304 (High Dose or Low Dose) for the Treatment of Center-involving Clinically Significant Macular Edema Associated With Diabetic Retinopathy

Conditions
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Diabetic Macular Edema

Intervention / Treatment
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* Drug: 2304 Eye Drops High Dose
* Drug: 2304 Eye Drops Low Dose
* Drug: Placebo Eye Drops


Participation Criteria
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Eligibility Criteria
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Main inclusion/exclusion criteria are listed below. Others may apply. Inclusion Criteria: Male or female, at least 18 years of age. Diagnosis of diabetes mellitus Patient must be able to self administer study drug. Clinically significant diabetic macular edema in at least one eye (study eye) involving the center of the macula: Mild to severe non proliferative diabetic retinopathy (Early Treatment Diabetic Retinopathy Study [ETDRS] grade between 20 and 53). BCVA score ≥ 34 letters and < 80 letters in the study eye. Women of childbearing potential must have a negative urine pregnancy test at Screening and be using two highly effective methods of contraception throughout the study. Male patients with partners of childbearing potential must agree to use at least one highly effective method of contraception throughout the study. Exclusion Criteria: Ocular conditions: Any ocular condition in the study eye that in the opinion of the investigator would prevent improvement in visual acuity. Proliferative diabetic retinopathy in the study eye. History of panretinal scatter photocoagulation(PRP)in the study eye within 4 months prior to screening, and/or anticipated need for PRP in the 3 months following randomization. Active optic disc or retinal neovascularization, rubeosis iridis, active or history of choroidal neovascularization in the study eye. History of pars plana vitrectomy at any time, intraocular surgery in the study eye within 90 days prior to screening. History of use of intravitreal injectable or periocular depots corticosteroids (other than triamcinolone acetonide)within 3 months prior to the screening visit in the study eye. Patients who have previously received triamcinolone acetonide in the study eye: The intended dose for each triamcinolone acetonide injection was more than 4 mg. The most recent dose was less than 3 months prior to the screening visit. Any treatment-related adverse event that was seen, and in the opinion of the investigator, has the potential to worsen or reoccur with study treatment. Patients who have previously received anti-VEGF therapy within 3 months prior to the screening visit in the study eye. Uncontrolled glaucoma or glaucoma treated by 2 or more medications. Aphakia or intraocular lens placement in the anterior chamber of the study eye. Any active ocular infection; any history of recurrent or chronic infection or inflammation in the study eye. History of herpetic infection in either eye. History of corneal pathology/surgery Contact lens use at any time during the study. Systemic conditions: Uncontrolled systemic disease. Poorly controlled diabetes mellitus. Impaired renal function Poorly controlled arterial hypertension

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2304 Eye Drops High Dose<br>2304 Eye Drops High Dose self-administered in the study eye during the treatment period | Drug: 2304 Eye Drops High Dose<br>* 2304 Eye Drops High Dose self-administered in the study eye during the treatment period<br>|
| Experimental: 2304 Eye Drops Low Dose<br>2304 Eye Drops Low Dose self-administered in the study eye during the treatment period | Drug: 2304 Eye Drops Low Dose<br>* 2304 Eye Drops Low Dose self-administered in the study eye during the treatment period<br>|
| Placebo Comparator: Placebo Eye Drops<br>Placebo Eye Drops self-administered in the study eye during the treatment period | Drug: Placebo Eye Drops<br>* Placebo Eye Drops self-administered in the study eye during the treatment period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline of central retinal thickness as determined by logOCT |  | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with an improvement in best corrected visual acuity (BCVA) |  | Week 12 | 
| Change in macular volume and retinal thickness from baseline to Week 12 and Week 24 |  | Baseline, Week 12, Week 24 |