Comparison of Intravitreal Ranibizumab and Macular Grid-pattern Laser for Treatment of Diabetic Macular Edema

Macular Edema Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00994799
• Other study ID #: CRFB002AHU04T
• Secondary ID: CRFB002DHU06T
• Status: Recruiting
• Phase: N/A
• First received: October 13, 2009
• Last updated: October 15, 2009
• Start date: July 2009
• Est. completion date: February 2011

Study information

• Verified date: October 2009
• Source: Szeged University
• Contact: Rozsa Degi, assoc prof
• Phone: +36 30 279 4330
• Email: drdegirozsa[@]freemail.hu
• Is FDA regulated: No
• Health authority: Hungary: National Institute of Pharmacy
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Edema
• Macular Edema

Intervention

Drug:
• ranibizumab
10mg/ml intravitreal injection

Radiation:
• macular grid-pattern laser
macular grid-pattern laser therapy

Locations

Country	Name	City	State
Hungary	Semmelweis University Department of Ophthalmology	Budapest
Hungary	University of Szeged, Medical and Pharmaceutical Center, Department of Ophthalmology	Szeged
Hungary	Csolnoky Ferenc County Hospital Dept of Ophthalmolgy	Veszprem

Sponsors (3)

Lead Sponsor	Collaborator
Szeged University	Csolnoky Ferenc County Hospital, Semmelweis University

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in best corrected visual acuity		12 months	No
Secondary	Mean change in retinal thickness as assessed with OCT		12 months	No
Secondary	Change in the extension of foveal avascular zone, foveal thickness and macular volume by FA and OCT, respectively.		12 months	No
Secondary	Change in retinal function (color vision,contrast sensitivity, multifocal ERG)		12 months	No
Secondary	Rate of adverse events		12 months	Yes