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

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetic Macular Edema

In brief

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.

Key facts

Study ID

NCT01319487

Run by

Fovea Pharmaceuticals SA

People needed

267

Starts

2011-05-01

Expected to finish

2012-06-01

Last updated by the study team

2012-08-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, at least 18 years of age.
• Diagnosis of diabetes mellitus
• Patient must be able to self administer study drug.
• Clinically significant diabetic macular edema in at least one eye ("study eye") involving the center of the macula:
• Mild to severe non proliferative diabetic retinopathy (Early Treatment Diabetic Retinopathy Study [ETDRS] grade between 20 and 53).
• BCVA score ≥ 34 letters and < 80 letters in the study eye.
• 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.
• Male patients with partners of childbearing potential must agree to use at least one highly effective method of contraception throughout the study.

You may not qualify if…

• Ocular conditions:
• Any ocular condition in the study eye that in the opinion of the investigator would prevent improvement in visual acuity.
• Proliferative diabetic retinopathy in the study eye.
• 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.
• Active optic disc or retinal neovascularization, rubeosis iridis, active or history of choroidal neovascularization in the study eye.
• History of pars plana vitrectomy at any time, intraocular surgery in the study eye within 90 days prior to screening.
• 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.
• 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.
• Patients who have previously received anti-VEGF therapy within 3 months prior to the screening visit in the study eye.
• Uncontrolled glaucoma or glaucoma treated by 2 or more medications.
• Aphakia or intraocular lens placement in the anterior chamber of the study eye.
• Any active ocular infection; any history of recurrent or chronic infection or inflammation in the study eye.
• History of herpetic infection in either eye.
• History of corneal pathology/surgery
• Contact lens use at any time during the study.
• Systemic conditions:
• Uncontrolled systemic disease.
• Poorly controlled diabetes mellitus.
• Impaired renal function
• Poorly controlled arterial hypertension

Where it is running

• Center 1116 — Phoenix, Arizona, United States
• Center 1108 — Fort Myers, Florida, United States
• Center 1106 — Chicago, Illinois, United States
• Center 1105 — Indianapolis, Indiana, United States
• Center 1101 — Boston, Massachusetts, United States
• Center 1109 — Boston, Massachusetts, United States
• Center 1111 — Boston, Massachusetts, United States
• Center 1114 — Traverse, Michigan, United States
• Center 1112 — Toms River, New Jersey, United States
• Center 1107 — Lynbrook, New York, United States
• Center 1110 — Pittburgh, Pennsylvania, United States
• Center 1104 — Nashville, Tennessee, United States
• Center 1103 — San Antonio, Texas, United States
• Center 2003 — Chatswood, Australia
• Center 2002 — Melbourne, Australia
• Center 2004 — Murdoch, Australia
• Center 2001 — Sydney, Australia
• Center 1302 — Antwerp, Belgium
• Center 1301 — Brussels, Belgium
• Center 1303 — Wilrijk, Belgium
• Center 1704 — Brno, Czechia
• Center 1701 — Hradec Králové, Czechia
• Center 1703 — Ostrava, Czechia
• Center 1702 — Prague, Czechia
• Center 1115 — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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