Clinical trial NCT01319487: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Macular Edema
Lead sponsor: Fovea Pharmaceuticals SA
Sponsor class: INDUSTRY
First posted: 2011-03-21
Enrollment: 267
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Exclusion Criteria:

Ocular conditions:

1. Any ocular condition in the study eye that in the opinion of the investigator would prevent improvement in visual acuity.
2. Proliferative diabetic retinopathy in the study eye.
3. 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.
4. Active optic disc or retinal neovascularization, rubeosis iridis, active or history of choroidal neovascularization in the study eye.
5. History of pars plana vitrectomy at any time, intraocular surgery in the study eye within 90 days prior to screening.
6. 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.
7. 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.
8. Patients who have previously received anti-VEGF therapy within 3 months prior to the screening visit in the study eye.
9. Uncontrolled glaucoma or glaucoma treated by 2 or more medications.
10. Aphakia or intraocular lens placement in the anterior chamber of the study eye.
11. Any active ocular infection; any history of recurrent or chronic infection or inflammation in the study eye.
12. History of herpetic infection in either eye.
13. History of corneal pathology/surgery
14. Contact lens use at any time during the study.

    Systemic conditions:
15. Uncontrolled systemic disease.
16. Poorly controlled diabetes mellitus.
17. Impaired renal function
18. Poorly controlled arterial hypertension

Primary outcomes:
measure: change from baseline of central retinal thickness as determined by logOCT
timeFrame: Week 12
Secondary outcomes:
measure: Proportion of patients with an improvement in best corrected visual acuity (BCVA)
timeFrame: Week 12
measure: Change in macular volume and retinal thickness from baseline to Week 12 and Week 24
timeFrame: Baseline, Week 12, Week 24
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Center 1115
state: Arizona
city: Phoenix
country: United States
facility: Center 1116
state: Arizona
city: Fort Myers
country: United States
facility: Center 1108
state: Florida
city: Chicago
country: United States
facility: Center 1106
state: Illinois
city: Indianapolis
country: United States
facility: Center 1105
state: Indiana
city: Boston
country: United States
facility: Center 1101
state: Massachusetts
city: Boston
country: United States
facility: Center 1109
state: Massachusetts
city: Boston
country: United States
facility: Center 1111
state: Massachusetts
city: Traverse
country: United States
facility: Center 1114
state: Michigan
city: Toms River
country: United States
facility: Center 1112
state: New Jersey
city: Lynbrook
country: United States
facility: Center 1107
state: New York
city: Pittburgh
country: United States
facility: Center 1110
state: Pennsylvania
city: Nashville
country: United States
facility: Center 1104
state: Tennessee
city: San Antonio
country: United States
facility: Center 1103
state: Texas
city: Chatswood
country: Australia
facility: Center 2003
city: Melbourne
country: Australia
facility: Center 2002
city: Murdoch
country: Australia
facility: Center 2004
city: Sydney
country: Australia
facility: Center 2001
city: Antwerpen
country: Belgium
facility: Center 1302
city: Brussels
country: Belgium
facility: Center 1301
city: Wilrijk
country: Belgium
facility: Center 1303
city: Brno
country: Czech Republic
facility: Center 1704
city: Hradec Kralove
country: Czech Republic
facility: Center 1701
city: Ostrava
country: Czech Republic
facility: Center 1703
city: Prague
country: Czech Republic
facility: Center 1702
city: Praha
country: Czech Republic
facility: Center 1705
city: Zlin
country: Czech Republic
facility: Center 1706
city: Dijon
country: France
facility: Center 1401
city: Marseille
country: France
facility: Center 1402
city: Nantes
country: France
facility: Center 1405
city: Paris
country: France
facility: Center 1403
city: Paris
country: France
facility: Center 1404
city: Ahaus
country: Germany
facility: Center 1504
city: Darmstadt
country: Germany
facility: Center 1502
city: Freiburg
country: Germany
facility: Center 1503
city: Karlsruhe
country: Germany
facility: Center 1501
city: Leipzig
country: Germany
facility: Center 1506
city: Munster
country: Germany
facility: Center 1507
city: Saarbruecken
country: Germany
facility: Center 1505
city: Afula
country: Israel
facility: Center 1907
city: Beer Sheva
country: Israel
facility: Center 1909
city: Beer Yakov
country: Israel
facility: Center 1906
city: Jerusalem
country: Israel
facility: Center 1903
city: Kfar-Saba
country: Israel
facility: Center 1908
city: Petah Tikva
country: Israel
facility: Center 1902
city: Rehovot
country: Israel
facility: Center 1901
city: Tel Aviv
country: Israel
facility: Center 1904
city: Tel Hashomer
country: Israel
facility: Center 1905
city: Firenze
country: Italy
facility: Center 1604
city: Milano
country: Italy
facility: Center 1601
city: Milano
country: Italy
facility: Center 1607
city: Rome
country: Italy
facility: Center 1610
city: Saronno
country: Italy
facility: Center 1606
city: Udine
country: Italy
facility: Center 1608
city: Verona
country: Italy
facility: Center 1609
city: Bydgoszcz
country: Poland
facility: Center1801
city: Gdansk
country: Poland
facility: Center 1802
city: Alicante
country: Spain
facility: Center 1205
city: Barcelona
country: Spain
facility: Center 1201
city: Barcelona
country: Spain
facility: Center 1202
city: Oviedo
country: Spain
facility: Center 1204
city: Santiago de Compostela
country: Spain
facility: Center 1206
city: Sevilla
country: Spain
facility: Center 1208
city: Valencia
country: Spain
facility: Center 1209
city: Valladolid
country: Spain
facility: Center 1203
Study officials:
affiliation: Lariboisière Hospital, Paris
name: Pascale Massin, MD
role: STUDY_CHAIR
References: