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

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.

Consented, enrolled subjects will receive multiple open-label intravitreal injections on 0.3mg ranibizumab administered every 30 days for 12 months per the treatment algorithm.

The patients will be randomized to 1 of 2 treatment groups. Group 1: Treatment algorithm based on the Diabetic Retinopathy Clinical Research (DRCR) protocol I 4:2:7 strategy based on the presence of macular edema.

Group 2: Continue treatment until not only the macular edema is resolved but also until the lipid exudate is resolved.

Sample size: 30 eyes Follow-up Schedule: Every 4 weeks throughout the study.

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