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

Diabetic Macular Edema Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01319487
• Other study ID #: FOV2304/CLIN/201/P
• Status: Completed
• Phase: Phase 2
• First received: March 18, 2011
• Last updated: August 22, 2012
• Start date: May 2011
• Est. completion date: June 2012

Study information

• Verified date: August 2012
• Source: Fovea Pharmaceuticals SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationAustralia: Human Research Ethics CommitteeBelgium: Federal Agency for Medicinal Products and Health ProductsBelgium: Institutional Review BoardCzech Republic: Ethics CommitteeCzech Republic: State Institute for Drug ControlFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: Institutional Ethical CommitteeGermany: Ethics CommissionGermany: Federal Institute for Drugs and Medical DevicesIsrael: Ethics CommissionIsrael: Ministry of HealthPoland: Ethics CommitteePoland: Ministry of HealthUnited States: Food and Drug AdministrationUnited States: Institutional Review BoardItaly: Ethics CommitteeSpain: Agencia Española de Medicamentos y Productos SanitariosSpain: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 267
• Est. completion date: June 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Diabetic Retinopathy
• Edema
• Macular Edema

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Australia	Center 2003	Chatswood
Australia	Center 2002	Melbourne
Australia	Center 2004	Murdoch
Australia	Center 2001	Sydney
Belgium	Center 1302	Antwerpen
Belgium	Center 1301	Brussels
Belgium	Center 1303	Wilrijk
Czech Republic	Center 1704	Brno
Czech Republic	Center 1701	Hradec Kralove
Czech Republic	Center 1703	Ostrava
Czech Republic	Center 1702	Prague
Czech Republic	Center 1705	Praha
Czech Republic	Center 1706	Zlin
France	Center 1401	Dijon
France	Center 1402	Marseille
France	Center 1405	Nantes
France	Center 1403	Paris
France	Center 1404	Paris
Germany	Center 1504	Ahaus
Germany	Center 1502	Darmstadt
Germany	Center 1503	Freiburg
Germany	Center 1501	Karlsruhe
Germany	Center 1506	Leipzig
Germany	Center 1507	Munster
Germany	Center 1505	Saarbruecken
Israel	Center 1907	Afula
Israel	Center 1909	Beer Sheva
Israel	Center 1906	Beer Yakov
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 Hashomer
Italy	Center 1604	Firenze
Italy	Center 1601	Milano
Italy	Center 1607	Milano
Italy	Center 1610	Rome
Italy	Center 1606	Saronno
Italy	Center 1608	Udine
Italy	Center 1609	Verona
Poland	Center1801	Bydgoszcz
Poland	Center 1802	Gdansk
Spain	Center 1205	Alicante
Spain	Center 1201	Barcelona
Spain	Center 1202	Barcelona
Spain	Center 1204	Oviedo
Spain	Center 1206	Santiago de Compostela
Spain	Center 1208	Sevilla
Spain	Center 1209	Valencia
Spain	Center 1203	Valladolid
United States	Center 1101	Boston	Massachusetts
United States	Center 1109	Boston	Massachusetts
United States	Center 1111	Boston	Massachusetts
United States	Center 1106	Chicago	Illinois
United States	Center 1108	Fort Myers	Florida
United States	Center 1105	Indianapolis	Indiana
United States	Center 1107	Lynbrook	New York
United States	Center 1104	Nashville	Tennessee
United States	Center 1115	Phoenix	Arizona
United States	Center 1116	Phoenix	Arizona
United States	Center 1110	Pittburgh	Pennsylvania
United States	Center 1103	San Antonio	Texas
United States	Center 1112	Toms River	New Jersey
United States	Center 1114	Traverse	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Fovea Pharmaceuticals SA

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline of central retinal thickness as determined by logOCT		Week 12	No
Secondary	Proportion of patients with an improvement in best corrected visual acuity (BCVA)		Week 12	No
Secondary	Change in macular volume and retinal thickness from baseline to Week 12 and Week 24		Baseline, Week 12, Week 24	No