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
- Conditions
- Diabetic Macular Edema
- Interventions
- Drug: 2304 Eye Drops High DoseDrug: 2304 Eye Drops Low DoseDrug: Placebo Eye Drops
- Registration Number
- NCT01319487
- Lead Sponsor
- Fovea Pharmaceuticals SA
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 267
- 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.
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2304 Eye Drops High Dose 2304 Eye Drops High Dose 2304 Eye Drops High Dose self-administered in the study eye during the treatment period 2304 Eye Drops Low Dose 2304 Eye Drops Low Dose 2304 Eye Drops Low Dose self-administered in the study eye during the treatment period Placebo Eye Drops Placebo Eye Drops Placebo Eye Drops self-administered in the study eye during the treatment period
- Primary Outcome Measures
Name Time Method change from baseline of central retinal thickness as determined by logOCT Week 12
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (65)
Center 1112
🇺🇸Toms River, New Jersey, United States
Center 1907
🇮🇱Afula, Israel
Center 1202
🇪🇸Barcelona, Spain
Center 1209
🇪🇸Valencia, Spain
Center 1403
🇫🇷Paris, France
Center 1302
🇧🇪Antwerpen, Belgium
Center 1205
🇪🇸Alicante, Spain
Center 1108
🇺🇸Fort Myers, Florida, United States
Center 2003
🇦🇺Chatswood, Australia
Center 2004
🇦🇺Murdoch, Australia
Center 1101
🇺🇸Boston, Massachusetts, United States
Center 1609
🇮🇹Verona, Italy
Center 1601
🇮🇹Milano, Italy
Center 1106
🇺🇸Chicago, Illinois, United States
Center 1905
🇮🇱Tel Hashomer, Israel
Center 1114
🇺🇸Traverse, Michigan, United States
Center 1116
🇺🇸Phoenix, Arizona, United States
Center 1204
🇪🇸Oviedo, Spain
Center 1901
🇮🇱Rehovot, Israel
Center 1904
🇮🇱Tel Aviv, Israel
Center1801
🇵🇱Bydgoszcz, Poland
Center 1802
🇵🇱Gdansk, Poland
Center 1206
🇪🇸Santiago de Compostela, Spain
Center 1208
🇪🇸Sevilla, Spain
Center 1203
🇪🇸Valladolid, Spain
Center 1604
🇮🇹Firenze, Italy
Center 1607
🇮🇹Milano, Italy
Center 1610
🇮🇹Rome, Italy
Center 1606
🇮🇹Saronno, Italy
Center 1608
🇮🇹Udine, Italy
Center 1201
🇪🇸Barcelona, Spain
Center 1115
🇺🇸Phoenix, Arizona, United States
Center 1111
🇺🇸Boston, Massachusetts, United States
Center 1110
🇺🇸Pittburgh, Pennsylvania, United States
Center 1103
🇺🇸San Antonio, Texas, United States
Center 1104
🇺🇸Nashville, Tennessee, United States
Center 2002
🇦🇺Melbourne, Australia
Center 2001
🇦🇺Sydney, Australia
Center 1303
🇧🇪Wilrijk, Belgium
Center 1703
🇨🇿Ostrava, Czech Republic
Center 1301
🇧🇪Brussels, Belgium
Center 1704
🇨🇿Brno, Czech Republic
Center 1701
🇨🇿Hradec Kralove, Czech Republic
Center 1705
🇨🇿Praha, Czech Republic
Center 1706
🇨🇿Zlin, Czech Republic
Center 1702
🇨🇿Prague, Czech Republic
Center 1401
🇫🇷Dijon, France
Center 1402
🇫🇷Marseille, France
Center 1405
🇫🇷Nantes, France
Center 1404
🇫🇷Paris, France
Center 1504
🇩🇪Ahaus, Germany
Center 1502
🇩🇪Darmstadt, Germany
Center 1501
🇩🇪Karlsruhe, Germany
Center 1506
🇩🇪Leipzig, Germany
Center 1503
🇩🇪Freiburg, Germany
Center 1902
🇮🇱Petah Tikva, Israel
Center 1909
🇮🇱Beer Sheva, Israel
Center 1507
🇩🇪Munster, Germany
Center 1505
🇩🇪Saarbruecken, Germany
Center 1903
🇮🇱Jerusalem, Israel
Center 1906
🇮🇱Beer Yakov, Israel
Center 1908
🇮🇱Kfar-Saba, Israel
Center 1109
🇺🇸Boston, Massachusetts, United States
Center 1105
🇺🇸Indianapolis, Indiana, United States
Center 1107
🇺🇸Lynbrook, New York, United States