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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Szeged University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Semmelweis University
Csolnoky Ferenc County Hospital
Information provided by:
Szeged University
ClinicalTrials.gov Identifier:
NCT00994799
First received: October 13, 2009
Last updated: October 15, 2009
Last verified: October 2009
  Purpose

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 Intervention
Macular Edema
Drug: ranibizumab
Radiation: macular grid-pattern laser

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Szeged University:

Primary Outcome Measures:
  • Mean change in best corrected visual acuity [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change in retinal thickness as assessed with OCT [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in the extension of foveal avascular zone, foveal thickness and macular volume by FA and OCT, respectively. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in retinal function (color vision,contrast sensitivity, multifocal ERG) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Rate of adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: July 2009
Estimated Study Completion Date: February 2011
Groups/Cohorts Assigned Interventions
ranibizumab group
patients receiving intravitreal ranibizumab for diabetic macular edema
Drug: ranibizumab
10mg/ml intravitreal injection
Other Name: Lucentis
laser
patients receiving macular grid-pattern laser therapy
Radiation: macular grid-pattern laser
macular grid-pattern laser therapy
Other Name: macular 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Diabetes patients having clinically significant macular edema due to diabetic retinopathy.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00994799

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

Locations
Hungary
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
Investigators
Principal Investigator: Lajos Kolozsvari, prof Szeged University
  More Information

No publications provided

Responsible Party: Lajos Kolozsvari Dr Prof, University of Szeged Department of Ophthalmology
ClinicalTrials.gov Identifier: NCT00994799     History of Changes
Other Study ID Numbers: CRFB002AHU04T, CRFB002DHU06T
Study First Received: October 13, 2009
Last Updated: October 15, 2009
Health Authority: Hungary: National Institute of Pharmacy

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on September 30, 2014