NCT00994799

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2009

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 14, 2009

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

October 16, 2009

Status Verified

October 1, 2009

First QC Date

October 13, 2009

Last Update Submit

October 15, 2009

Conditions

Macular Edema

Outcome Measures

Primary Outcomes (1)

  • Mean change in best corrected visual acuity

    12 months

Secondary Outcomes (4)

  • Mean change in retinal thickness as assessed with OCT

    12 months

  • Change in the extension of foveal avascular zone, foveal thickness and macular volume by FA and OCT, respectively.

    12 months

  • Change in retinal function (color vision,contrast sensitivity, multifocal ERG)

    12 months

  • Rate of adverse events

    12 months

Study Arms (2)

ranibizumab group

patients receiving intravitreal ranibizumab for diabetic macular edema

Drug: ranibizumab

laser

patients receiving macular grid-pattern laser therapy

Radiation: macular grid-pattern laser

Interventions

ranibizumabDRUG

10mg/ml intravitreal injection

Also known as: Lucentis
ranibizumab group
macular grid-pattern laserRADIATION

macular grid-pattern laser therapy

Also known as: macular laser
laser

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Semmelweis University Department of Ophthalmology

Budapest, H-1085, Hungary

RECRUITING

University of Szeged, Medical and Pharmaceutical Center, Department of Ophthalmology

Szeged, H-6721, Hungary

RECRUITING

Csolnoky Ferenc County Hospital Dept of Ophthalmolgy

Veszprém, H-8200, Hungary

RECRUITING

MeSH Terms

Conditions

Macular Edema

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Lajos Kolozsvari, prof

    Szeged University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rozsa Degi, assoc prof

CONTACT

+36 30 279 4330drdegirozsa@freemail.hu

Barbara B Toth, assistlect

CONTACT

+36 30 239 3020btothbarbara@freemail.hu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 13, 2009

First Posted

October 14, 2009

Study Start

July 1, 2009

Study Completion

February 1, 2011

Last Updated

October 16, 2009

Record last verified: 2009-10

Locations

HU(3)