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

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ClinicalTrials.gov Identifier: NCT00994799
Recruitment Status : Unknown
Verified October 2009 by Szeged University.
Recruitment status was:  Recruiting
First Posted : October 14, 2009
Last Update Posted : October 16, 2009
Information provided by:

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
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
Estimated 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 : July 2009
Estimated Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
Drug Information available for: Ranibizumab
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
ranibizumab group
patients receiving intravitreal ranibizumab for diabetic macular edema
Drug: ranibizumab
10mg/ml intravitreal injection
Other Name: Lucentis
patients receiving macular grid-pattern laser therapy
Radiation: macular grid-pattern laser
macular grid-pattern laser therapy
Other Name: macular laser

Outcome Measures

Primary Outcome Measures :
  1. Mean change in best corrected visual acuity [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Mean change in retinal thickness as assessed with OCT [ Time Frame: 12 months ]
  2. Change in the extension of foveal avascular zone, foveal thickness and macular volume by FA and OCT, respectively. [ Time Frame: 12 months ]
  3. Change in retinal function (color vision,contrast sensitivity, multifocal ERG) [ Time Frame: 12 months ]
  4. Rate of adverse events [ Time Frame: 12 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Diabetes patients having clinically significant macular edema due to diabetic retinopathy.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00994799

Contact: Rozsa Degi, assoc prof +36 30 279 4330 drdegirozsa@freemail.hu
Contact: Barbara B Toth, assistlect +36 30 239 3020 btothbarbara@freemail.hu

Semmelweis University Department of Ophthalmology Recruiting
Budapest, Hungary, H-1085
Contact: Zsuzsanna Recsan, lecturer    +36 30 253 6759    recsan@szem2.sote.hu   
Principal Investigator: Zsuzsanna Recsan, lecturer         
University of Szeged, Medical and Pharmaceutical Center, Department of Ophthalmology Recruiting
Szeged, Hungary, H-6721
Contact: Rozsa Degi, assoc prof    +36 30 279 4330    drdegirozsa@freemail.hu   
Contact: Barbara B Toth, assist lect    +36 30 239 3020    btothbarbara@freemail.hu   
Principal Investigator: Rozsa Degi, assoc prof         
Sub-Investigator: Barbara B Toth, assist lect         
Csolnoky Ferenc County Hospital Dept of Ophthalmolgy Recruiting
Veszprem, Hungary, H-8200
Contact: Jozsef Gyory, head of dept    +36 70 379 1622    gyjf@hotmail.com   
Principal Investigator: Jozsef Gyory, head of dept         
Sponsors and Collaborators
Szeged University
Semmelweis University
Csolnoky Ferenc County Hospital
Principal Investigator: Lajos Kolozsvari, prof Szeged University
More Information

Responsible Party: Lajos Kolozsvari Dr Prof, University of Szeged Department of Ophthalmology
ClinicalTrials.gov Identifier: NCT00994799     History of Changes
Other Study ID Numbers: CRFB002AHU04T
First Posted: October 14, 2009    Key Record Dates
Last Update Posted: October 16, 2009
Last Verified: October 2009

Additional relevant MeSH terms:
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents