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

• Sponsor: Szeged University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00994799
• Collaborator: Semmelweis University (Other), Csolnoky Ferenc County Hospital (Other)
• Enrollment: 50
• Locations: 3
• Duration (Months): 19.1
• Patients Per Site: 16.7
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Macular Edema	Drug: ranibizumab; Radiation: macular grid-pattern laser

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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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 Start Date: Jul 1, 2009
• Anticipated Study Completion Date: Feb 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
ranibizumab group patients receiving intravitreal ranibizumab for diabetic macular edema	Drug: ranibizumab; 10mg/ml intravitreal injection; Other Names: Lucentis
laser patients receiving macular grid-pattern laser therapy	Radiation: macular grid-pattern laser; macular grid-pattern laser therapy; Other Names: macular laser

Outcome Measures

Primary Outcome Measures

1. Mean change in best corrected visual acuity [12 months]

Secondary Outcome Measures

1. Mean change in retinal thickness as assessed with OCT [12 months]

2. Change in the extension of foveal avascular zone, foveal thickness and macular volume by FA and OCT, respectively. [12 months]

3. Change in retinal function (color vision,contrast sensitivity, multifocal ERG) [12 months]

4. Rate of adverse events [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Semmelweis University Department of Ophthalmology	Budapest		Hungary	H-1085
2	University of Szeged, Medical and Pharmaceutical Center, Department of Ophthalmology	Szeged		Hungary	H-6721
3	Csolnoky Ferenc County Hospital Dept of Ophthalmolgy	Veszprem		Hungary	H-8200

Sponsors and Collaborators

• Szeged University
• Semmelweis University
• Csolnoky Ferenc County Hospital

Investigators

• Principal Investigator: Lajos Kolozsvari, prof, Szeged University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00994799
• Other Study ID Numbers: CRFB002AHU04T; CRFB002DHU06T
• First Posted: Oct 14, 2009
• Last Update Posted: Oct 16, 2009
• Last Verified: Oct 1, 2009

• Additional relevant MeSH terms: Macular Edema; Edema; Ranibizumab

Study Results

No Results Posted as of Oct 16, 2009