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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01319487
• Date of registration: 18/03/2011
• Prospective Registration: Yes
• Primary sponsor: Fovea Pharmaceuticals SA
• Public title: 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
• Scientific 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
• Date of first enrolment: May 2011
• Target sample size: 267
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01319487
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

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

Contacts

• Name: Pascale Massin, MD
• Affiliation: Lariboisière Hospital, Paris

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetic Macular Edema

Intervention(s)

Drug: 2304 Eye Drops High Dose

Drug: Placebo Eye Drops

Drug: 2304 Eye Drops Low Dose

Primary Outcome(s)

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

Secondary Outcome(s)

Change in macular volume and retinal thickness from baseline to Week 12 and Week 24 [Time Frame: Baseline, Week 12, Week 24]

Proportion of patients with an improvement in best corrected visual acuity (BCVA) [Time Frame: Week 12]

Secondary ID(s)

FOV2304/CLIN/201/P

Source(s) of Monetary Support

Please refer to primary and secondary sponsors