Lucentis (Ranibizumab) for Eales' Disease

This is an interventional treatment trial for Eales' Disease focused on measuring Eales Read More

Inclusion Criteria:

• Ability to provide written informed consent and comply with study assessments for the full duration of the study.
• Age > 21 years.
• Disease related considerations:

• For both treatment naïve and previously treated patients:

  • exclusion of all other causes of cystoid macular edema and retinal nonperfusion including branch or central vein occlusion, diabetic retinopathy, sickle retinopathy, sarcoidosis, systemic lupus and other collagen vascular diseases
  • chronic cystoid macular edema as noted clinically and on OCT 3 testing with persistent loss of visual acuity for 3 months or longer
  • if the eye has received prior treatment (including laser photocoagulation and steroids) a 30 day washout period will be required prior to treatment with Lucentis.
• BCVA using ETDRS charts of 20/40 to 20/400 (Snellen equivalent) in the study eye.
• OCT 3 central subfield > or = 250 on 2 separate readings in the central subfield.
• Only one eye will be assessed in the study. If both eyes are eligible, the investigator will determine which eye will be entered into the study.

Exclusion Criteria:

• Treatment for macular edema with intravitreal steroid or macugen within 30 days prior to enrollment in this study.
• Previous vitrectomy within the past 6 months.
• Previous cataract surgery within the preceding 12 months.
• Active intraocular inflammation in the study eye.
• Current vitreous hemorrhage in the study eye.
• Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye.
• A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control).
• Participation in an investigational trial within 30 days of randomization that involved.
• Treatment with any drug that has not received regulatory approval at the time of study entry.
• Known allergy to any component of the study drug.
• Blood pressure > 180/110 (systolic above 180 OR diastolic above 110).
• If blood pressure is brought below 180/110 by anti-hypertensive treatment, subject can become eligible.
• Major surgery within 28 days prior to randomization or major surgery planned during the next 6 months. Major surgery is defined as a surgical procedure that is more extensive than fine needle biopsy/aspiration, placement of a central venous access device, removal/biopsy of a skin lesion, or placement of a peripheral venous catheter.
• Myocardial infarction, other cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 6 months prior to randomization.
• Systemic anti-VEGF or pro-VEGF treatment within 3 months prior to randomization.
• Systemic anti-VEGF or pro-VEGF treatment used during the 6 months of the study.
• Current treatment for active systemic infection.
• History of recurrent significant infections or bacterial infections.
• Subject is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the 6 months of the study.

• Subjects meeting any of the following criteria will be excluded from the study:

  • Pregnancy (positive pregnancy test).
  • Prior enrollment in the study.
  • 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.