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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fovea Pharmaceuticals SA
ClinicalTrials.gov Identifier:
NCT01319487
First received: March 18, 2011
Last updated: August 22, 2012
Last verified: August 2012
  Purpose
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 Intervention Phase
Diabetic Macular Edema Drug: 2304 Eye Drops High Dose Drug: 2304 Eye Drops Low Dose Drug: Placebo Eye Drops Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Fovea Pharmaceuticals SA:

Primary Outcome Measures:
  • change from baseline of central retinal thickness as determined by logOCT [ Time Frame: Week 12 ]

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

Enrollment: 267
Study Start Date: May 2011
Study Completion Date: June 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01319487

  Show 65 Study Locations
Sponsors and Collaborators
Fovea Pharmaceuticals SA
Investigators
Study Chair: Pascale Massin, MD Lariboisière Hospital, Paris
  More Information

Responsible Party: Fovea Pharmaceuticals SA
ClinicalTrials.gov Identifier: NCT01319487     History of Changes
Other Study ID Numbers: FOV2304/CLIN/201/P
Study First Received: March 18, 2011
Last Updated: August 22, 2012

Additional relevant MeSH terms:
Edema
Macular Edema
Diabetic Retinopathy
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Ophthalmic Solutions
Tetrahydrozoline
Pharmaceutical Solutions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on September 21, 2017