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

August 22, 2012 updated by: Fovea Pharmaceuticals SA

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

267

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Chatswood, Australia
        • Center 2003
      • Melbourne, Australia
        • Center 2002
      • Murdoch, Australia
        • Center 2004
      • Sydney, Australia
        • Center 2001
  • Belgium
      • Antwerpen, Belgium
        • Center 1302
      • Brussels, Belgium
        • Center 1301
      • Wilrijk, Belgium
        • Center 1303
  • Czech Republic
      • Brno, Czech Republic
        • Center 1704
      • Hradec Kralove, Czech Republic
        • Center 1701
      • Ostrava, Czech Republic
        • Center 1703
      • Prague, Czech Republic
        • Center 1702
      • Praha, Czech Republic
        • Center 1705
      • Zlin, Czech Republic
        • Center 1706
  • France
      • Dijon, France
        • Center 1401
      • Marseille, France
        • Center 1402
      • Nantes, France
        • Center 1405
      • Paris, France
        • Center 1403
      • Paris, France
        • Center 1404
  • Germany
      • Ahaus, Germany
        • Center 1504
      • Darmstadt, Germany
        • Center 1502
      • Freiburg, Germany
        • Center 1503
      • Karlsruhe, Germany
        • Center 1501
      • Leipzig, Germany
        • Center 1506
      • Munster, Germany
        • Center 1507
      • Saarbruecken, Germany
        • Center 1505
  • Israel
      • Afula, Israel
        • Center 1907
      • Beer Sheva, Israel
        • Center 1909
      • Beer Yakov, Israel
        • Center 1906
      • Jerusalem, Israel
        • Center 1903
      • Kfar-Saba, Israel
        • Center 1908
      • Petah Tikva, Israel
        • Center 1902
      • Rehovot, Israel
        • Center 1901
      • Tel Aviv, Israel
        • Center 1904
      • Tel Hashomer, Israel
        • Center 1905
  • Italy
      • Firenze, Italy
        • Center 1604
      • Milano, Italy
        • Center 1601
      • Milano, Italy
        • Center 1607
      • Rome, Italy
        • Center 1610
      • Saronno, Italy
        • Center 1606
      • Udine, Italy
        • Center 1608
      • Verona, Italy
        • Center 1609
  • Poland
      • Bydgoszcz, Poland
        • Center1801
      • Gdansk, Poland
        • Center 1802
  • Spain
      • Alicante, Spain
        • Center 1205
      • Barcelona, Spain
        • Center 1201
      • Barcelona, Spain
        • Center 1202
      • Oviedo, Spain
        • Center 1204
      • Santiago de Compostela, Spain
        • Center 1206
      • Sevilla, Spain
        • Center 1208
      • Valencia, Spain
        • Center 1209
      • Valladolid, Spain
        • Center 1203
  • United States
    • Arizona
      • Phoenix, Arizona, United States
        • Center 1115
      • Phoenix, Arizona, United States
        • Center 1116
    • Florida
      • Fort Myers, Florida, United States
        • Center 1108
    • Illinois
      • Chicago, Illinois, United States
        • Center 1106
    • Indiana
      • Indianapolis, Indiana, United States
        • Center 1105
    • Massachusetts
      • Boston, Massachusetts, United States
        • Center 1101
      • Boston, Massachusetts, United States
        • Center 1109
      • Boston, Massachusetts, United States
        • Center 1111
    • Michigan
      • Traverse, Michigan, United States
        • Center 1114
    • New Jersey
      • Toms River, New Jersey, United States
        • Center 1112
    • New York
      • Lynbrook, New York, United States
        • Center 1107
    • Pennsylvania
      • Pittburgh, Pennsylvania, United States
        • Center 1110
    • Tennessee
      • Nashville, Tennessee, United States
        • Center 1104
    • Texas
      • San Antonio, Texas, United States
        • Center 1103

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change from baseline of central retinal thickness as determined by logOCT
Time Frame: Week 12
Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with an improvement in best corrected visual acuity (BCVA)
Time Frame: Week 12
Week 12
Change in macular volume and retinal thickness from baseline to Week 12 and Week 24
Time Frame: Baseline, Week 12, Week 24
Baseline, Week 12, Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fovea Pharmaceuticals SA

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (ACTUAL)

March 1, 2012

Study Completion (ACTUAL)

June 1, 2012

Study Registration Dates

First Submitted

March 18, 2011

First Submitted That Met QC Criteria

March 18, 2011

First Posted (ESTIMATE)

March 21, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

August 23, 2012

Last Update Submitted That Met QC Criteria

August 22, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FOV2304/CLIN/201/P

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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