The Ranibizumab for Edema of the mAcula in Diabetes-2 (READ-2) Study
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Intervention: Ranibizumab; Laser photocoagulation
Intervention description: Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and pro re nata (PRN) with dosing criteria.; Laser photocoagulation in either focal or grid pattern as determined by investigator.
Intervention MeSH terms: Ranibizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 126.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: DME

Summary:

      This study is being done to see if the investigational drug Ranibizumab (RBZ) given by
      injection into the eye, is safe and effective to use in people with diabetic macular edema
      (DME). The investigators want to compare RBZ to laser treatment which is the current standard
      way to treat DME.

      RBZ blocks a growth factor that is thought to be involved in the formation of abnormal blood
      vessels that cause loss of vision in patients with DME.
    

Eligibility criteria:

        Inclusion:

          -  Signed informed consent and authorization of use and disclosure of protected health
             information

          -  Age greater than 18 years

          -  Diagnosis of diabetes mellitus (type 1 or type 2) and serum HbA1c greater than 5.5%
             within 12 months of randomization

          -  Retinal thickening secondary to diabetes mellitus (diabetic macular edema) involving
             the center of the fovea.

          -  Diagnosis must be confirmed by OCT images

          -  Foveal thickness of greater than 250, as assessed by OCT

          -  Best corrected visual acuity score in the study eye of 20/40 to 20/320 inclusive
             (Snellen equivalents using the ETDRS protocol at a distance of 4 meters). Only one eye
             will be treated in the study. If both eyes are eligible, the investigator will select
             the eye to be enrolled. Visual acuity in the non-study eye must be greater than
             20/800.

          -  In the opinion of the investigator, decreased vision in the study eye is due to foveal
             thickening from DME and not from other obvious causes.

          -  In the opinion of the investigator, laser photocoagulation can be withheld for at
             least 30 days after the patient has enrolled in the study

        Exclusion Criteria:

          -  Panretinal photocoagulation or macular photocoagulation within 3 months of study entry
             in the study eye

          -  Use of intraocular or periocular injection of steroids in the study eye (e.g.,
             triamcinolone) within 3 months of study entry

          -  Previous participation in a study and receipt of anti-angiogenic drugs (pegaptanib
             sodium, ranibizumab, anecortave acetate, protein kinase C inhibitor, etc.) within 2
             months of study entry

          -  Eyes in which the investigators do not feel appropriate to do any additional laser
             photocoagulation

          -  Proliferative diabetic retinopathy in the study eye, with the exceptions of inactive,
             fibrotic proliferative diabetic retinopathy that has regressed following pan-retinal
             laser photocoagulation or tufts of neovascularization elsewhere (NVE) less than one
             disc area with no vitreous hemorrhage

          -  Vitreomacular traction or epiretinal membrane in the study eye evident
             biomicroscopically or by OCT

          -  Structural damage to the center of the macula in the study eye likely to preclude
             improvement in visual acuity following the resolution of macular edema, including
             atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s), macular
             ischemia, or organized hard exudate plaque

          -  Ocular disorders in the study eye that may confound interpretation of study results,
             including retinal vascular occlusion, retinal detachment, macular hole, or choroidal
             neovascularization of any cause (e.g., age related macular degeneration (AMD), ocular
             histoplasmosis, or pathologic myopia)

          -  Concurrent disease in the study eye that could compromise visual acuity or require
             medical or surgical intervention during the first 6-month study period

          -  Eyes which are likely to need cataract surgery and intraocular lens implantation
             within the first 6 months of the study

          -  Cataract surgery in the study eye within 3 months of study entry;
             Yttrium-Aluminum-Garnet (YAG) laser capsulotomy within 2 months of study entry; or any
             other intraocular surgery within 3 months preceding Day 0.

          -  History of vitreoretinal surgery in the study eye within 3 months of study entry

          -  Uncontrolled glaucoma (defined as intraocular pressure greater than 30 mm Hg despite
             treatment with anti-glaucoma medications)

          -  Uncontrolled diabetes mellitus, as evidenced by glycosylated hemoglobin (HbA1c) value
             greater than 12%

          -  Premenopausal women not using adequate contraception

          -  Any women who are pregnant

          -  International normalized ratio (INR) greater than or equal to 3.0 (e.g. due to current
             treatment with warfarin). The use of aspirin or other anticoagulants is not an
             exclusion

          -  History of gastrointestinal bleeding within 2 months of study enrollment

          -  History of major gastrointestinal, cardiothoracic, gynecological, genitourinary, or
             orthopedic surgeries within 2 months of study enrollment

          -  History of cerebral vascular accident, myocardial infarction, transient ischemic
             attacks within 6 months of study enrollment

          -  Any patients who are on renal dialysis