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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01319487

Enrollment

267

Registered

2011-03-21

Start date

2011-05-31

Completion date

2012-06-30

Last updated

2012-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Macular Edema

Brief summary

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.

Interventions

DRUGPlacebo Eye Drops

Placebo Eye Drops self-administered in the study eye during the treatment period

DRUG2304 Eye Drops High Dose

2304 Eye Drops High Dose self-administered in the study eye during the treatment period

DRUG2304 Eye Drops Low Dose

2304 Eye Drops Low Dose self-administered in the study eye during the treatment period

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Main inclusion/

Exclusion criteria

are listed below. Others may apply. Inclusion Criteria: 1. Male or female, at least 18 years of age. 2. Diagnosis of diabetes mellitus 3. Patient must be able to self administer study drug. 4. Clinically significant diabetic macular edema in at least one eye (study eye) involving the center of the macula: 5. Mild to severe non proliferative diabetic retinopathy (Early Treatment Diabetic Retinopathy Study \[ETDRS\] grade between 20 and 53). 6. BCVA score ≥ 34 letters and \< 80 letters in the study eye. 7. 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. 8. Male patients with partners of childbearing potential must agree to use at least one highly effective method of contraception throughout the study.

Design outcomes

Primary

Measure	Time frame
change from baseline of central retinal thickness as determined by logOCT	Week 12

Secondary

Measure	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

Countries

Australia, Belgium, Czechia, France, Germany, Israel, Italy, Poland, Spain, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026