The Effect of Intravitreal Ranibizumab on Visual Acuity and Hard Exudate Resolution in the Treatment of Diabetic Macular Edema With Center Involved Edema and Lipid Exudates

Completed · Phase 1/Phase 2

Conditions studied: Diabetic Macular Edema, Hard Lipid Exudates

In brief

This is an open-label, Phase I/II study of intravitreally administered 0.3mg ranibizumab in subjects with diabetic macular edema and lipid exudates in the central subfield.

Key facts

Study ID

NCT02448446

Run by

South Coast Retina Center; Carson, McBeath, Boswell, Inc.

People needed

25

Starts

2015-08-01

Expected to finish

2018-05-01

Last updated by the study team

2021-07-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Ability to provide written informed consent and comply with study assessments for the full duration of the study
• Age ≥ 18 years
• Type 1 or Type 2 Diabetes mellitus
• Best corrected ETDRS visual acuity (20/32-20/320) or letter score 78 to 24
• Diabetic macular edema on clinical examination involving the center of the macula assessed to be the main cause of visual loss
• Retinal thickness measured on spectral domain optical coherence tomography (OCT). Zeiss Cirrus: ≥290μm in women and ≥305 μm in men in the central subfield. Heidelberg Spectralis: ≥305μm in women and ≥320 μm in men in the central subfield
• Lipid exudates involving the central subfield on spectral domain OCT.

You may not qualify if…

• Subjects who meet any of the following criteria will be excluded from this study:
• Treatment for diabetic macular edema within the prior 4 months.
• Panretinal photocoagulation within the prior 4 months or anticipated need for panretinal photocoagulation within the next 6 months
• major ocular surgery within the prior 4 months
• myocardial infarction, other cardiac event requiring hospitalization, cerebrovascular accident, transient ischemic attack, or treatment for acute congestive heart failure occurred within 4 months before randomization
• Pregnancy (positive pregnancy test) or lactation
• Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an intrauterine device (IUD), or contraceptive hormone implant or patch.
• Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
• Participation in another simultaneous medical investigation or trial

Where it is running

• South Coast Retina Center; Carson, McBeath, Boswell, Inc — Huntington Beach, California, United States
• South Coast Retina Center; Carson, McBeath, and Boswell, Inc — Long Beach, California, United States
• Retina Partners — Santa Monica, California, United States
• South Coast Retina Center; Carson, McBeath, Boswell, Inc — Torrance, California, United States

Full record on ClinicalTrials.gov

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