Clinical trial NCT00994799: Comparison of Intravitreal Ranibizumab and Macular Grid-pattern Laser for Treatment of Diabetic Macular Edema
Official title: Comparison of the Effect of Intravitreal Ranibizumab Injections Compared to Macular Grid-pattern Laser Therapy for the Symptomatic Treatment of Diabetic Macular Edema (a Randomized, Controlled, Phase III Trial)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Macular Edema
Lead sponsor: Szeged University
Sponsor class: OTHER
Collaborators: name: Semmelweis University
name: Csolnoky Ferenc County Hospital
First posted: 2009-10-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Diabetes patients having clinically significant macular edema due to diabetic retinopathy.

Brief summary: This study investigates the hypothesis that ranibizumab injection given into the eye is an efficacious and safe treatment option applied for swelling of the macula (site of sharp vision) in diabetes.

Detailed description: This is a randomized, controlled, three-center trial to assess the efficacy and safety of intravitreal ranibizumab injections in diabetic macular edema. Comparator arm consists of patients receiving macular grid-pattern laser therapy.

Eligibility criteria: Inclusion Criteria:

* Male or female type I or II diabetic patients over 18 years of age
* Diagnosis of DME secondary to diabetic retinopathy and decrease in vision is due to DME and not due to other causes in the opinion of the investigator
* Patients who have a BCVA score between 78 and 39 letters in the study eye using ETDRS-like visual acuity charts at a testing distance of 4 meters
* Expectation by the investigator that patient will potentially benefit from laser treatment or ranibizumab treatment
* Willing and able to comply with all study procedures

Exclusion Criteria:

* Active intraocular inflammation, any active infection or history of uveitis
* Uncontrolled glaucoma or neovascularization of the iris in the study eye
* Structural damage within 0.5 disc diameter of 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), epiretinal membrane involving fovea or organized hard exudate plaques
* Concurrent disease in the study eye that could compromise visual acuity or prevent the improvement of visual acuity (including diabetic proliferative retinopathy) or require medical or surgical intervention during the study period, including cataract, retinal vascular occlusion, retinal detachment, macular hole or choroidal neovascularization of any cause
* Panretinal laser photocoagulation in the study eye within 6 months prior to or during the study or focal/grid laser photocoagulation in the study eye within 3 months prior to study entry
* Treatment with anti-angiogenic drugs (pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc) or intravitreal corticosteroids in the study eye within 3 months prior to randomization
* Any intraocular surgery in the study eye within 3 months prior to randomization
* History of vitrectomy in the study eye
* Ocular conditions in the study eye that require chronic concomitant therapy with topical ocular or systemically administered corticosteroids
* Pregnancy and lactation

Primary outcomes:
measure: Mean change in best corrected visual acuity
timeFrame: 12 months
Secondary outcomes:
measure: Mean change in retinal thickness as assessed with OCT
timeFrame: 12 months
measure: Change in the extension of foveal avascular zone, foveal thickness and macular volume by FA and OCT, respectively.
timeFrame: 12 months
measure: Change in retinal function (color vision,contrast sensitivity, multifocal ERG)
timeFrame: 12 months
measure: Rate of adverse events
timeFrame: 12 months
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University Department of Ophthalmology
city: Szeged
country: Hungary
facility: University of Szeged, Medical and Pharmaceutical Center, Department of Ophthalmology
city: Veszprem
country: Hungary
facility: Csolnoky Ferenc County Hospital Dept of Ophthalmolgy
Study officials:
affiliation: Szeged University
name: Lajos Kolozsvari, prof
role: PRINCIPAL_INVESTIGATOR
References: