A study to compare the safety and effectiveness of two concentrations of FOV2304 to placebo in the treatment of diabetic macular edema.

A 6-month, Phase II, Double-masked, Multicenter, Randomized, Placebocontrolled, Parallel Group Study to Assess the Safety and Efficacy of Topical Administration of Two Concentrations of FOV2304 Twice Daily for the Treatment of Center-involving Clinically Significant Macular Edema Associated with Diabetic Retinopathy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-021291-29-DE

Enrollment

261

Registered

2010-12-27

Start date

2011-04-26

Completion date

Unknown

Last updated

2013-01-07

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

Conditions

Clinically significant diabetic macular edema in at least one eye involving the center of the macula MedDRA version: 14.0 Level: LLT Classification code 10057934 Term: Diabetic macular edema System Organ Class: 10015919 - Eye disorders

Interventions

Product Name: FOV2304/SOL2/low dose Product Code: FOV2304/SOL2/low dose Pharmaceutical Form: Eye drops, solution INN or Proposed INN: safotibant Current Sponsor code: FOV2304 Other descriptive name: F

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male or female, at least 18 years of age 2. Written, signed informed consent obtained 3. Diagnosis of diabetes mellitus 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 6. 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. 7. Male patients with partners of childbearing potential must agree to use at least one highly effective method of contraception throughout the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 78 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 183

Exclusion criteria

Exclusion criteria: 1. Any ocular condition in the study eye that in the opinion of the investigator would prevent improvement in visual acuity (including but not limited to severe macular ischemia, foveal atrophy, pigmentary changes, dense subfoveal hard exudates, nonretinal condition)

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the study is to determine whether two concentrations of FOV2304 is more effective than placebo in decreasing mean central retinal thickness following 12 weeks of treatment for patients with DME.;Secondary Objective: The secondary objectives of the study are to estimate the effects of two concentrations of FOV2304 compared with placebo on visual acuity, retinal thickness and macular volume following 12 weeks of treatment and after a further 12 weeks of follow-up, the requirement for rescue therapy during the safety follow-up period and to assess the safety, tolerability, and pharmacokinetics (PK) of FOV2304 in the treatment of patients with DME.;Primary end point(s): The primary endpoint is the change from baseline of CRT (central retinal thickness) as determined by logOCT (optical coherence tomography) following up to 12 weeks of treatment.;Timepoint(s) of evaluation of this end point: The change from baseline of CRT (central retinal thickness) will be examined over the 12 week treatment period.	—

Measure

Time frame

Main Objective: The primary objective of the study is to determine whether two concentrations of FOV2304 is more effective than placebo in decreasing mean central retinal thickness following 12 weeks of treatment for patients with DME.;Secondary Objective: The secondary objectives of the study are to estimate the effects of two concentrations of FOV2304 compared with placebo on visual acuity, retinal thickness and macular volume following 12 weeks of treatment and after a further 12 weeks of follow-up, the requirement for rescue therapy during the safety follow-up period and to assess the safety, tolerability, and pharmacokinetics (PK) of FOV2304 in the treatment of patients with DME.;Primary end point(s): The primary endpoint is the change from baseline of CRT (central retinal thickness) as determined by logOCT (optical coherence tomography) following up to 12 weeks of treatment.;Timepoint(s) of evaluation of this end point: The change from baseline of CRT (central retinal thickness) will be examined over the 12 week treatment period.

—

Secondary

Measure	Time frame
Secondary end point(s): Proportion of patients with an improvement in BCVA (best corrected visual acuity). Change in macular volume edema;Timepoint(s) of evaluation of this end point: Following up to 12 and 24 weeks of treatment	—

Countries

Australia, Belgium, Czech Republic, France, Germany, Israel, Italy, Poland, Spain, United States

Contacts

Public ContactTransparency Manager

Fovea Pharmaceuticals SA

contact-us@sanofi-aventis.com+33 1 44 16 42 42

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026