Ranibizumab for Edema of the Macula in Diabetes: a Phase 2 Study ( The Read-2 Study)
Overview
- Phase
- Phase 2
- Intervention
- Ranibizumab
- Conditions
- Diabetic Macular Edema
- Sponsor
- Johns Hopkins University
- Enrollment
- 126
- Locations
- 20
- Primary Endpoint
- Mean Change in Best Corrected Visual Acuity (BCVA) at Month 6
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief 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.
Detailed Description
The READ-2 Study is a phase 2 randomized, multi-center clinical trial to be conducted under an investigator-initiated investigational new drug (IND). The study aims to enroll 126 patients, who will be randomized into 3 different groups. The primary objectives of the READ-2 Study are: (a) to obtain data on the bioactivity and dose interval effects of intravitreal ranibizumab (RBZ) alone, as well as in combination with laser photocoagulation, on retinal thickness and visual acuity in subjects with DME; and (b) to obtain additional safety and bioactivity data to aid in the design of a phase 3 clinical trial to evaluate ranibizumab as a therapeutic option for patients with DME The study consists of a 2-week screening period (Days -14 to 0), a 6-month treatment period with a primary time endpoint, and a 18-month follow-up and treatment period with secondary time endpoints. Consented subjects will enter the 14-day screening period to determine eligibility. Serum chemistry and hematology testing, urinalysis, pregnancy testing, and macular thickness measurements based on optical coherence tomography (OCT) will be performed. Screening will also include VA, ophthalmic examination and fluorescein angiography (FA) entry criteria. Patients who have ETDRS visual acuity of 20/40 or worse, but better than or equal to 20/320 due to foveal thickening from macular edema secondary to diabetes (type 1 or 2) and who meet eligibility criteria will be eligible to enroll in the study. Baseline foveal thickness by OCT must be at least 250, which is often associated with VA of 20/40 or worse and which provides sufficient thickening so that a treatment effect is easily detectable (Nguyen et al. 2004). Approximately 126 patients with DME will be enrolled in this study from all clinical sites in the study. Every effort will be made to recruit and enroll eligible patients from men and women of all ethnic and social backgrounds. Patients who meet entry criteria will be able to enroll in the study until the quota of patients has been achieved.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
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
Arms & Interventions
Ranibizumab
Ranibizumab (RBZ) intravitreal injection alone
Intervention: Ranibizumab
Laser
Laser photocoagulation
Intervention: Laser photocoagulation
Laser with Ranibizumab
Laser following intravitreal injection of RBZ
Intervention: Ranibizumab
Laser with Ranibizumab
Laser following intravitreal injection of RBZ
Intervention: Laser photocoagulation
Outcomes
Primary Outcomes
Mean Change in Best Corrected Visual Acuity (BCVA) at Month 6
Time Frame: 6 months
Mean change of best corrected visual acuity letters (BCVA) at month 6