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
1 other identifier
interventional
267
10 countries
65
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2011
Shorter than P25 for phase_2
65 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 18, 2011
CompletedFirst Posted
Study publicly available on registry
March 21, 2011
CompletedStudy Start
First participant enrolled
May 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedAugust 23, 2012
August 1, 2012
10 months
March 18, 2011
August 22, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
change from baseline of central retinal thickness as determined by logOCT
Week 12
Secondary Outcomes (2)
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
Study Arms (3)
2304 Eye Drops High Dose
EXPERIMENTAL2304 Eye Drops High Dose self-administered in the study eye during the treatment period
2304 Eye Drops Low Dose
EXPERIMENTAL2304 Eye Drops Low Dose self-administered in the study eye during the treatment period
Placebo Eye Drops
PLACEBO COMPARATORPlacebo Eye Drops self-administered in the study eye during the treatment period
Interventions
2304 Eye Drops High Dose self-administered in the study eye during the treatment period
2304 Eye Drops Low Dose self-administered in the study eye during the treatment period
Placebo Eye Drops self-administered in the study eye during the treatment period
Eligibility Criteria
You may not qualify if:
- 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.
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (65)
Center 1115
Phoenix, Arizona, United States
Center 1116
Phoenix, Arizona, United States
Center 1108
Fort Myers, Florida, United States
Center 1106
Chicago, Illinois, United States
Center 1105
Indianapolis, Indiana, United States
Center 1101
Boston, Massachusetts, United States
Center 1109
Boston, Massachusetts, United States
Center 1111
Boston, Massachusetts, United States
Center 1114
Traverse, Michigan, United States
Center 1112
Toms River, New Jersey, United States
Center 1107
Lynbrook, New York, United States
Center 1110
Pittburgh, Pennsylvania, United States
Center 1104
Nashville, Tennessee, United States
Center 1103
San Antonio, Texas, United States
Center 2003
Chatswood, Australia
Center 2002
Melbourne, Australia
Center 2004
Murdoch, Australia
Center 2001
Sydney, Australia
Center 1302
Antwerp, Belgium
Center 1301
Brussels, Belgium
Center 1303
Wilrijk, Belgium
Center 1704
Brno, Czechia
Center 1701
Hradec Králové, Czechia
Center 1703
Ostrava, Czechia
Center 1702
Prague, Czechia
Center 1705
Prague, Czechia
Center 1706
Zlín, Czechia
Center 1401
Dijon, France
Center 1402
Marseille, France
Center 1405
Nantes, France
Center 1403
Paris, France
Center 1404
Paris, France
Center 1504
Ahaus, Germany
Center 1502
Darmstadt, Germany
Center 1503
Freiburg im Breisgau, Germany
Center 1501
Karlsruhe, Germany
Center 1506
Leipzig, Germany
Center 1507
Münster, Germany
Center 1505
Saarbrücken, Germany
Center 1907
Afula, Israel
Center 1906
Beer Yakov, Israel
Center 1909
Beersheba, Israel
Center 1903
Jerusalem, Israel
Center 1908
Kfar Saba, Israel
Center 1902
Petah Tikva, Israel
Center 1901
Rehovot, Israel
Center 1904
Tel Aviv, Israel
Center 1905
Tel Litwinsky, Israel
Center 1604
Florence, Italy
Center 1601
Milan, Italy
Center 1607
Milan, Italy
Center 1610
Rome, Italy
Center 1606
Saronno, Italy
Center 1608
Udine, Italy
Center 1609
Verona, Italy
Center1801
Bydgoszcz, Poland
Center 1802
Gdansk, Poland
Center 1205
Alicante, Spain
Center 1201
Barcelona, Spain
Center 1202
Barcelona, Spain
Center 1204
Oviedo, Spain
Center 1206
Santiago de Compostela, Spain
Center 1208
Seville, Spain
Center 1209
Valencia, Spain
Center 1203
Valladolid, Spain
Study Officials
- STUDY CHAIR
Pascale Massin, MD
Lariboisière Hospital, Paris
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2011
First Posted
March 21, 2011
Study Start
May 1, 2011
Primary Completion
March 1, 2012
Study Completion
June 1, 2012
Last Updated
August 23, 2012
Record last verified: 2012-08