Macular EdemaNCT00994799
Comparison of Intravitreal Ranibizumab and Macular Grid-pattern Laser for Treatment of Diabetic Macular Edema
An observational study of Macular Edema, run by Szeged University at 3 sites in Hungary.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Edema
- What is being tested?
- ranibizumab and macular grid-pattern laser
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 50 participants
- Where
- 3 sitesHungary
- Study dates
- Jul 2009to Feb 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diabetes patients having clinically significant macular edema due to diabetic retinopathy.
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Hungary3 sites, 3 recruiting
- Recruiting
Semmelweis University Department of Ophthalmology
Budapest, H-1085
Zsuzsanna Recsan, lecturer, +36 30 253 6759, recsan@szem2.sote.hu
Zsuzsanna Recsan, lecturer
- Recruiting
University of Szeged, Medical and Pharmaceutical Center, Department of Ophthalmology
Szeged, H-6721
Rozsa Degi, assoc prof, +36 30 279 4330, drdegirozsa@freemail.hu
Barbara B Toth, assist lect, +36 30 239 3020, btothbarbara@freemail.hu
- Recruiting
Csolnoky Ferenc County Hospital Dept of Ophthalmolgy
Veszprém, H-8200
Jozsef Gyory, head of dept, +36 70 379 1622, gyjf@hotmail.com
Jozsef Gyory, head of dept
About this study
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)
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.
Read the 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.
- Conditions
- Macular Edema
- Being tested
- ranibizumab, macular grid-pattern laser
- Medical subject headings
- Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ranibizumabDrug
Also called Lucentis
10mg/ml intravitreal injection
macular grid-pattern laserRadiation
Also called macular laser
macular grid-pattern laser therapy
| Study group | Role | What they receive |
|---|---|---|
| ranibizumab group | patients receiving intravitreal ranibizumab for diabetic macular edema Receives: Drug: ranibizumab | |
| laser | patients receiving macular grid-pattern laser therapy Receives: Radiation: macular grid-pattern laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in best corrected visual acuity
Measured: 12 months
Secondary outcomes (4)
Mean change in retinal thickness as assessed with OCT
Measured: 12 months
Change in the extension of foveal avascular zone, foveal thickness and macular volume by FA and OCT, respectively.
Measured: 12 months
Change in retinal function (color vision,contrast sensitivity, multifocal ERG)
Measured: 12 months
Rate of adverse events
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2009 (estimated)
- Study startJul 2009
- Study completionFeb 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Szeged University
- Sponsor type
- University, hospital or other
- Collaborators
- Semmelweis University, Csolnoky Ferenc County Hospital
- Investigators
- Lajos Kolozsvari, prof, Principal investigator, Szeged University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00994799
- Sponsor's protocol ID
- CRFB002AHU04T
- Other IDs
- CRFB002DHU06T
- Status last verified
- Oct 2009
- First submitted
- 13 Oct 2009
- Last updated
- 16 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00994799
- Acronym / sponsor ID
- CRFB002AHU04T
- Conditions
- Macular Edema
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Szeged UniversityUniversity, hospital or other
- Collaborators
- Semmelweis University, Csolnoky Ferenc County Hospital
- Study start
- Jul 2009
- Study completion
- Feb 2011 (estimated)
- First posted
- 14 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ranibizumab group | – | Drug: ranibizumabpatients receiving intravitreal ranibizumab for diabetic macular edema |
| laser | – | Radiation: macular grid-pattern laserpatients receiving macular grid-pattern laser therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetes patients having clinically significant macular edema due to diabetic retinopathy.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ranibizumabAlso: Lucentis10mg/ml intravitreal injection | Drug | ranibizumab group |
| macular grid-pattern laserAlso: macular lasermacular grid-pattern laser therapy | Radiation | laser |
Primary outcome
Mean change in best corrected visual acuity
Time frame: 12 months
4 secondary outcomes
Mean change in retinal thickness as assessed with OCT
Time frame: 12 months
Change in the extension of foveal avascular zone, foveal thickness and macular volume by FA and OCT, respectively.
Time frame: 12 months
Change in retinal function (color vision,contrast sensitivity, multifocal ERG)
Time frame: 12 months
Rate of adverse events
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lajos Kolozsvari, prof principal investigator
Szeged University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Macular Edema, run by Szeged University at 3 sites in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rozsa Degi, assoc prof (+36 30 279 4330, drdegirozsa@freemail.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in best corrected visual acuity (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2009.