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
NCT ID: NCT01319487
Last Updated: 2012-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
267 participants
INTERVENTIONAL
2011-05-31
2012-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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2304 Eye Drops High Dose
2304 Eye Drops High Dose self-administered in the study eye during the treatment period
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 self-administered in the study eye during the treatment period
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 self-administered in the study eye during the treatment period
Placebo Eye Drops
Placebo Eye Drops self-administered in the study eye during the treatment period
Interventions
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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 self-administered in the study eye during the treatment period
Placebo Eye Drops
Placebo Eye Drops self-administered in the study eye during the treatment period
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Fovea Pharmaceuticals SA
INDUSTRY
Responsible Party
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Principal Investigators
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Pascale Massin, MD
Role: STUDY_CHAIR
Lariboisière Hospital, Paris
Locations
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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
Countries
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Other Identifiers
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FOV2304/CLIN/201/P
Identifier Type: -
Identifier Source: org_study_id