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

• Status: Completed
• Trial end date: 2018-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: South Coast Retina Center; Carson, McBeath, Boswell, Inc.
• Collaborators: Doheny Image Reading Center; Genentech, Inc.; Retina Partners
• Treatments: Ranibizumab

Criteria

Subjects will be eligible if the following criteria are met:

Inclusion Criteria

• 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.

Exclusion Criteria

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