Diabetic Macular EdemaPhase 2/3MORENCT00885794
Microperimetry and Optical Coherence Tomography (OCT) With Lucentis for Diabetic Macular Edema (DME)
A Phase 2/3 study testing Ranibizumab in people with Diabetic Macular Edema, run by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery at 1 site in Austria.
Trial summary
Diabetic maculopathy is the leading cause of visual impairment in the working-age population in developed countries. Diabetic macular edema can cause impaired visual acuity and so far is treated by laser, vitreous surgery, and intravitreal cortisone application. Still 50% of the cases do not respond to the treatment. Read more about this study
- Who is it for?
- Ages 51 years and older
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- Ranibizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteAustria
- Study dates
- May 2008to May 2012
- Phase
- Phase 2/3
- 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 51 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Study eye with clinically significant macular edema, for which one of the following characteristics has to be present:
- retinal thickening at or within 500µm from the center of the macula,
- hard exudates at or within 500µm from the center of the macula associated with thickening of the adjacent retina,
- a zone (>1-disk area) or zones of retinal thickening of which any part is within 1 disk diameter from the center of the macula.
- Second line treatment after ineffective laser treatment
- Men or women with diabetes mellitus
Show all 9Show fewer
- Only one eye per patient
- Age > 50 years
- HbA1c < 8%
Who cannot join
- Study eye with concomitant retinal or choroidal disorder other than diabetic retinopathy
- Study eye with significant central lens opacities and / or conditions that limit the view of the fundus
- poor general condition
- woman of childbearing potential, current pregnancy or breastfeeding
- Patients who are unwilling to adhere to visit examination schedules
- Evidence of macular traction or taut posterior hyloid.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Microperimetry and High-Definition-OCT in Ranibizumab Treatment for Diabetic Macular Edema (MORE-Study)
Diabetic maculopathy is the leading cause of visual impairment in the working-age population in developed countries. Diabetic macular edema can cause impaired visual acuity and so far is treated by laser, vitreous surgery, and intravitreal cortisone application. Still 50% of the cases do not respond to the treatment.
Recently intraocular anti-VEGF-treatment with ranibizumab (Lucentis®, Novartis) in diabetic macular edema has proven efficacy to last over a period of 3 to 6 months. Still, the optimal dosage for those intravitreal injections still has to be found, because frequent injections are necessary.
Read more
The measurement of visual acuity is inadequate to quantify in detail the visual impairment. Using the newest technology of a high-definition optical coherence tomography (Cirrus-OCT, Carl Zeiss Meditec Inc.) to determine the retinal thickness, and a miroperimetry (MP-1, Nidek Technologies) to determine retinal sensitivity, we hope to find the optimal dosage of intravitreal anti-VEGF treatment in diabetic macular edema.
Study objective: To determine the dose response of 0.5mg and 1.0mg ranibizumab (Lucentis®, Novartis Pharma) intravitreal injection in subjects with resistant diabetic macular edema and evaluate safety and tolerability.
Read the detailed description
Diabetic maculopathy due to diabetic macular edema (DME) is the leading cause of visual impairment in the working-age population in developed countries. DME is the swelling of the retina resulting from the exudation and accumulation of extracellular fluid and proteins in the macula. Structural changes in the endothelium of retinal vessels lead to a breakdown of the blood-retina barrier and increase vascular permeability, resulting in exudation. The standardized treatment of DME is a focal laser or GRID-laser treatment with or without combined triamcinolone intravitreal injections. Those laser treatments produce scars in the central retina and are not always very effective. In cases of macular traction or taut posterior hyloid vitrectomy and retinal surgery are necessary.
Vascular endothelial growth factor (VEGF) has been implicated as an important factor in the occurrence of vascular permeability in DME. In patients with DME, VEGF levels are significantly elevated, compared to patients without ocular disease. Therefore, anti-VEGF treatment has been implicated as an important treatment of DME and recently intraocular anti-VEGF-treatment with ranibizumab (Lucentis®, Novartis Pharma) in diabetic macular edema has proven to be very effective. Just like in patients with age-related macular degeneration (AMD), anti-VEGF treatment was given 3 times every 4-6 weeks. The same treatment was repeated at a relapse of the disease, again 3 times every 4-6 weeks. One study group treated DME with 0.5mg ranibizumab intravitreal injections and the other compared 0.3mg to 0.5mg of ranibizumab intravitreal injections. An optimal treatment dose has not been found yet.
Visual acuity assessment is currently used to determine the functional damage caused by edema, although it may not completely describe the functional condition of the patient. Furthermore, visual acuity alone does not seem to be the best parameter to define the effect and continuation of treatment. Retinal thickness, as measured by the noninvasive optical coherence tomography (OCT) can deliver detailed information about the retinal situation during and after treatment. Also a fundus related perimetry, known as microperimetry (MP), is a useful noninvasive examination method in determining the site of relative and absolute scotomas and also fixation characteristics. With MP the macular sensitivity can be measured to further assess the macular condition.
Using the newest technology of a high-definition OCT (Cirrus-OCT, Carl Zeiss Meditec Inc.) to determine the retinal thickness, and a MP with automated correction for eye movements (MP-1, Nidek Technologies) to determine retinal sensitivity, we intend to analyze this new treatment option for DME, and find the optimized dose for intravitreal injection of ranibizumab in cases of ineffective laser treatment.
- Conditions
- Diabetic Macular Edema
- Being tested
- Ranibizumab
- Keywords
- Clinically Significant Diabetic Macular Edema, Focal Laser, GRID-Laser, Ranibizumab, Lucentis, Microperimetry, High-Definition OCT, Randomized, Observer-Blinded, Ineffective Treatment with Focal Laser or GRID-Laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanibizumabDrug
Also called Lucentis
3 intravitreal injection every 5 weeks
| Study group | Role | What they receive |
|---|---|---|
| 0.5 mg Ranibizumab | Experimental | 3 intravitreal injections of 0.5 mg Ranibizumab every 5 weeks Receives: Drug: Ranibizumab |
| 1.0 mg of Ranibizumab | Experimental | 3 intravitreal injections of 1.0mg Ranibizumab every 5 weeks Receives: Drug: Ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal thickness
Measured: at 3 months
Secondary outcomes (8)
Retinal sensitivity
Measured: 3, 6, and 9 months
Distance best corrected visual acuity
Measured: 3, 6, and 9 months
Reading best corrected visual acuity
Measured: 3, 6, and 9 months
Intraocular pressure
Measured: 3, 6, and 9 months
Type of diabetic macular edema
Measured: 3, 6, and 9 months
Type of diabetes mellitus HbA1c
Measured: 3, 6, and 9 months
Blood-pressure
Measured: 3, 6, and 9 months
Age
Measured: 3, 6, and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2009 (estimated)
- Study startMay 2008
- Primary completionMay 2011
- Study completionMay 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
- Sponsor type
- University, hospital or other
- Investigators
- Ulrike Stolba, MD, Principal investigator, Department of Ophthalmology, Ludwig Boltzmann Institute for Retinology and Biomicroscopic Lasersurgery, Rudolf Foundation Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00885794
- Sponsor's protocol ID
- EK 08-069-0508
- Acronym
- MORE
- Status last verified
- Jun 2011
- First submitted
- 20 Apr 2009
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microperimetry and High-Definition-OCT in Ranibizumab Treatment for Diabetic Macular Edema (MORE-Study)
- ClinicalTrials.gov ID
- NCT00885794
- Acronym / sponsor ID
- MORE / EK 08-069-0508
- Conditions
- Diabetic Macular Edema
- Keywords
- Clinically Significant Diabetic Macular Edema, Focal Laser, GRID-Laser, Ranibizumab, Lucentis, Microperimetry, High-Definition OCT, Randomized
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser SurgeryUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- May 2011 (actual)
- Study completion
- May 2012 (estimated)
- First posted
- 22 Apr 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.
Diabetic maculopathy is the leading cause of visual impairment in the working-age population in developed countries. Diabetic macular edema can cause impaired visual acuity and so far is treated by laser, vitreous surgery, and intravitreal cortisone application. Still 50% of the cases do not respond to the treatment.
Recently intraocular anti-VEGF-treatment with ranibizumab (Lucentis®, Novartis) in diabetic macular edema has proven efficacy to last over a period of 3 to 6 months. Still, the optimal dosage for those intravitreal injections still has to be found, because frequent injections are necessary.
The measurement of visual acuity is inadequate to quantify in detail the visual impairment. Using the newest technology of a high-definition optical coherence tomography (Cirrus-OCT, Carl Zeiss Meditec Inc.) to determine the retinal thickness, and a miroperimetry (MP-1, Nidek Technologies) to determine retinal sensitivity, we hope to find the optimal dosage of intravitreal anti-VEGF treatment in diabetic macular edema.
Study objective: To determine the dose response of 0.5mg and 1.0mg ranibizumab (Lucentis®, Novartis Pharma) intravitreal injection in subjects with resistant diabetic macular edema and evaluate safety and tolerability.
Detailed description
Diabetic maculopathy due to diabetic macular edema (DME) is the leading cause of visual impairment in the working-age population in developed countries. DME is the swelling of the retina resulting from the exudation and accumulation of extracellular fluid and proteins in the macula. Structural changes in the endothelium of retinal vessels lead to a breakdown of the blood-retina barrier and increase vascular permeability, resulting in exudation. The standardized treatment of DME is a focal laser or GRID-laser treatment with or without combined triamcinolone intravitreal injections. Those laser treatments produce scars in the central retina and are not always very effective. In cases of macular traction or taut posterior hyloid vitrectomy and retinal surgery are necessary.
Vascular endothelial growth factor (VEGF) has been implicated as an important factor in the occurrence of vascular permeability in DME. In patients with DME, VEGF levels are significantly elevated, compared to patients without ocular disease. Therefore, anti-VEGF treatment has been implicated as an important treatment of DME and recently intraocular anti-VEGF-treatment with ranibizumab (Lucentis®, Novartis Pharma) in diabetic macular edema has proven to be very effective. Just like in patients with age-related macular degeneration (AMD), anti-VEGF treatment was given 3 times every 4-6 weeks. The same treatment was repeated at a relapse of the disease, again 3 times every 4-6 weeks. One study group treated DME with 0.5mg ranibizumab intravitreal injections and the other compared 0.3mg to 0.5mg of ranibizumab intravitreal injections. An optimal treatment dose has not been found yet.
Visual acuity assessment is currently used to determine the functional damage caused by edema, although it may not completely describe the functional condition of the patient. Furthermore, visual acuity alone does not seem to be the best parameter to define the effect and continuation of treatment. Retinal thickness, as measured by the noninvasive optical coherence tomography (OCT) can deliver detailed information about the retinal situation during and after treatment. Also a fundus related perimetry, known as microperimetry (MP), is a useful noninvasive examination method in determining the site of relative and absolute scotomas and also fixation characteristics. With MP the macular sensitivity can be measured to further assess the macular condition.
Using the newest technology of a high-definition OCT (Cirrus-OCT, Carl Zeiss Meditec Inc.) to determine the retinal thickness, and a MP with automated correction for eye movements (MP-1, Nidek Technologies) to determine retinal sensitivity, we intend to analyze this new treatment option for DME, and find the optimized dose for intravitreal injection of ranibizumab in cases of ineffective laser treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.5 mg Ranibizumab | Experimental | Drug: Ranibizumab3 intravitreal injections of 0.5 mg Ranibizumab every 5 weeks |
| 1.0 mg of Ranibizumab | Experimental | Drug: Ranibizumab3 intravitreal injections of 1.0mg Ranibizumab every 5 weeks |
Who may qualify
- Ages
- 51 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Study eye with clinically significant macular edema, for which one of the following characteristics has to be present:
- retinal thickening at or within 500µm from the center of the macula,
- hard exudates at or within 500µm from the center of the macula associated with thickening of the adjacent retina,
- a zone (>1-disk area) or zones of retinal thickening of which any part is within 1 disk diameter from the center of the macula.
- Second line treatment after ineffective laser treatment
Key exclusion criteria (6 listed)
- Study eye with concomitant retinal or choroidal disorder other than diabetic retinopathy
- Study eye with significant central lens opacities and / or conditions that limit the view of the fundus
- poor general condition
- woman of childbearing potential, current pregnancy or breastfeeding
- Patients who are unwilling to adhere to visit examination schedules
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: Lucentis3 intravitreal injection every 5 weeks | Drug | 0.5 mg Ranibizumab, 1.0 mg of Ranibizumab |
Primary outcome
Retinal thickness
Time frame: at 3 months
8 secondary outcomes
Retinal sensitivity
Time frame: 3, 6, and 9 months
Distance best corrected visual acuity
Time frame: 3, 6, and 9 months
Reading best corrected visual acuity
Time frame: 3, 6, and 9 months
Intraocular pressure
Time frame: 3, 6, and 9 months
Type of diabetic macular edema
Time frame: 3, 6, and 9 months
Type of diabetes mellitus HbA1c
Time frame: 3, 6, and 9 months
Blood-pressure
Time frame: 3, 6, and 9 months
Age
Time frame: 3, 6, and 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2011.
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RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
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Surabgene Lomparvovec Administered in the Suprachoroidal Space in Adult Participants With Diabetic Retinopathy Without Center-Involved Diabetic Macular Edema
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A Randomized, Phase 2 Study of Oral BGE-102 in Participants With Center-Involved Diabetic Macular Edema
Diabetic Macular Edema (DME)
Active, not recruitingObservational study
Long-Term Follow-up Study of ADVM-022 in DME (INFINITY-EXT)
Diabetic Macular Edema, Diabetic Retinopathy
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.
Ulrike Stolba, MD principal investigator
Department of Ophthalmology, Ludwig Boltzmann Institute for Retinology and Biomicroscopic Lasersurgery, Rudolf Foundation Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ranibizumab in people with Diabetic Macular Edema, run by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery at 1 site in Austria.
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 9 inclusion and 6 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 27 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal thickness (time frame: at 3 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 27 Jun 2011.