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

• Sponsor: Fovea Pharmaceuticals SA (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01319487
• Collaborator: (none)
• Enrollment: 267
• Locations: 65
• Arms: 3
• Duration (Months): 13
• Patients Per Site: 4.1
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Macular Edema	Drug: 2304 Eye Drops High Dose; Drug: 2304 Eye Drops Low Dose; Drug: Placebo Eye Drops	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 267 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: May 1, 2011
• Actual Primary Completion Date: Mar 1, 2012
• Actual Study Completion Date: Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 2304 Eye Drops High Dose 2304 Eye Drops High Dose self-administered in the study eye during the treatment period	Drug: 2304 Eye Drops High Dose; 2304 Eye Drops High Dose self-administered in the study eye during the treatment period
Experimental: 2304 Eye Drops Low Dose 2304 Eye Drops Low Dose self-administered in the study eye during the treatment period	Drug: 2304 Eye Drops Low Dose; 2304 Eye Drops Low Dose self-administered in the study eye during the treatment period
Placebo Comparator: Placebo Eye Drops Placebo Eye Drops self-administered in the study eye during the treatment period	Drug: Placebo Eye Drops; Placebo Eye Drops self-administered in the study eye during the treatment period

Outcome Measures

Primary Outcome Measures

1. change from baseline of central retinal thickness as determined by logOCT [Week 12]

Secondary Outcome Measures

1. Proportion of patients with an improvement in best corrected visual acuity (BCVA) [Week 12]

2. Change in macular volume and retinal thickness from baseline to Week 12 and Week 24 [Baseline, Week 12, Week 24]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

1. Patients who have previously received anti-VEGF therapy within 3 months prior to the screening visit in the study eye.

2. Uncontrolled glaucoma or glaucoma treated by 2 or more medications.

3. Aphakia or intraocular lens placement in the anterior chamber of the study eye.

4. Any active ocular infection; any history of recurrent or chronic infection or inflammation in the study eye.

5. History of herpetic infection in either eye.

6. History of corneal pathology/surgery

7. Contact lens use at any time during the study.

Systemic conditions:

1. Uncontrolled systemic disease.

2. Poorly controlled diabetes mellitus.

3. Impaired renal function

4. Poorly controlled arterial hypertension

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center 1115	Phoenix	Arizona	United States
2	Center 1116	Phoenix	Arizona	United States
3	Center 1108	Fort Myers	Florida	United States
4	Center 1106	Chicago	Illinois	United States
5	Center 1105	Indianapolis	Indiana	United States
6	Center 1101	Boston	Massachusetts	United States
7	Center 1109	Boston	Massachusetts	United States
8	Center 1111	Boston	Massachusetts	United States
9	Center 1114	Traverse	Michigan	United States
10	Center 1112	Toms River	New Jersey	United States
11	Center 1107	Lynbrook	New York	United States
12	Center 1110	Pittburgh	Pennsylvania	United States
13	Center 1104	Nashville	Tennessee	United States
14	Center 1103	San Antonio	Texas	United States
15	Center 2003	Chatswood		Australia
16	Center 2002	Melbourne		Australia
17	Center 2004	Murdoch		Australia
18	Center 2001	Sydney		Australia
19	Center 1302	Antwerpen		Belgium
20	Center 1301	Brussels		Belgium
21	Center 1303	Wilrijk		Belgium
22	Center 1704	Brno		Czech Republic
23	Center 1701	Hradec Kralove		Czech Republic
24	Center 1703	Ostrava		Czech Republic
25	Center 1702	Prague		Czech Republic
26	Center 1705	Praha		Czech Republic
27	Center 1706	Zlin		Czech Republic
28	Center 1401	Dijon		France
29	Center 1402	Marseille		France
30	Center 1405	Nantes		France
31	Center 1403	Paris		France
32	Center 1404	Paris		France
33	Center 1504	Ahaus		Germany
34	Center 1502	Darmstadt		Germany
35	Center 1503	Freiburg		Germany
36	Center 1501	Karlsruhe		Germany
37	Center 1506	Leipzig		Germany
38	Center 1507	Munster		Germany
39	Center 1505	Saarbruecken		Germany
40	Center 1907	Afula		Israel
41	Center 1909	Beer Sheva		Israel
42	Center 1906	Beer Yakov		Israel
43	Center 1903	Jerusalem		Israel
44	Center 1908	Kfar-Saba		Israel
45	Center 1902	Petah Tikva		Israel
46	Center 1901	Rehovot		Israel
47	Center 1904	Tel Aviv		Israel
48	Center 1905	Tel Hashomer		Israel
49	Center 1604	Firenze		Italy
50	Center 1601	Milano		Italy
51	Center 1607	Milano		Italy
52	Center 1610	Rome		Italy
53	Center 1606	Saronno		Italy
54	Center 1608	Udine		Italy
55	Center 1609	Verona		Italy
56	Center1801	Bydgoszcz		Poland
57	Center 1802	Gdansk		Poland
58	Center 1205	Alicante		Spain
59	Center 1201	Barcelona		Spain
60	Center 1202	Barcelona		Spain
61	Center 1204	Oviedo		Spain
62	Center 1206	Santiago de Compostela		Spain
63	Center 1208	Sevilla		Spain
64	Center 1209	Valencia		Spain
65	Center 1203	Valladolid		Spain

Sponsors and Collaborators

• Fovea Pharmaceuticals SA

Investigators

• Study Chair: Pascale Massin, MD, Lariboisière Hospital, Paris

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fovea Pharmaceuticals SA
• ClinicalTrials.gov Identifier: NCT01319487
• Other Study ID Numbers: FOV2304/CLIN/201/P
• First Posted: Mar 21, 2011
• Last Update Posted: Aug 23, 2012
• Last Verified: Aug 1, 2012

• Additional relevant MeSH terms: Macular Edema; Diabetic Retinopathy; Edema; Ophthalmic Solutions

Study Results

No Results Posted as of Aug 23, 2012