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

• Register: EUCTR
• Last refreshed on: 7 January 2013
• Main ID: EUCTR2010-021291-29-DE
• Date of registration: 27/12/2010
• Prospective Registration: Yes
• Primary sponsor: Fovea Pharmaceuticals SA
• Public title: A study to compare the safety and effectiveness of two concentrations of FOV2304 to placebo in the treatment of diabetic macular edema.
• Scientific title: 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
• Date of first enrolment: 26/04/2011
• Target sample size: 261
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-021291-29
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 3

Countries of recruitment

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

Contacts

• Name: Transparency Manager
• Affiliation: Fovea Pharmaceuticals SA

• Name: Transparency Manager
• Affiliation: Fovea Pharmaceuticals SA

Key inclusion & exclusion 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:
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)


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Therapeutic area: Diseases [C] - Eye Diseases [C11]

Intervention(s)

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: FOV2304
Concentration unit: % (W/V) percent weight/volume
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Eye drops, solution
Route of administration of the placebo: Ocular use

Product Name: FOV2304/SOL2/high dose
Product Code: FOV2304/SOL2/high dose
Pharmaceutical Form: Eye drops, solution
INN or Proposed INN: safotibant
Current Sponsor code: FOV2304
Other descriptive name: FOV2304
Concentration unit: % (W/V) percent weight/volume
Concentration type: equal
Concentration number: 2-
Pharmaceutical form of the placebo: Eye drops, solution
Route of administration of the placebo: Ocular use

Primary Outcome(s)

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 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.

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 Outcome(s)

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

Secondary ID(s)

NCT01319487

FOV2304/CLIN/201/P

Source(s) of Monetary Support

Fovea Pharmaceuticals SA