Visual Impairment Due to Diabetic Macular EdemaPhase 3RELATIONNCT01131585
Safety and Efficacy of Ranibizumab in Diabetic Macular Edema
A Phase 3 study testing Active laser photocoagulation and Ranibizumab 0.5 mg in people with Visual Impairment Due to Diabetic Macular Edema, run by Novartis Pharmaceuticals at 34 sites in Germany.
Trial summary
This study was designed to confirm the efficacy and safety of laser photocoagulation as adjunctive therapy to ranibizumab 0.5 mg versus laser monotherapy in patients with visual impairment due to Diabetic Macular Edema. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Visual Impairment Due to Diabetic Macular Edema
- What is being tested?
- Active laser photocoagulation and Ranibizumab 0.5 mg
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 34 sitesGermany
- Study dates
- Jun 2010to Jul 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Visual acuity impairment caused by macular edema in at least one eye
- Type 1 or type 2 diabetes mellitus
- Stable medication of diabetes in past 3 month
Who cannot join
- Patients with uncontrolled systemic or ocular diseases
- Laser photocoagulation in the study eye for the last 3 months
- Any history of any intraocular surgery in the study eye within the past 3 months
- Blood pressure > 160/100 mmHg
- Other protocol defined inclusion/exclusion criteria may apply
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
Germany34 sites
Novartis Investigative Site
Aschaffenburg
Novartis Investigative Site
Berlin
Novartis Investigative Site
Bonn
Novartis Investigative Site
Bremen
Novartis Investigative Site
Chemnitz
Novartis Investigative Site
Cologne
Novartis Investigative Site
Darmstadt
Novartis Investigative Site
Dessau
Novartis Investigative Site
Dortmund
Novartis Investigative Site
Dresden
Novartis Investigative Site
Eichstätt
Novartis Investigative Site
Essen
Novartis Investigative Site
Frankfurt
Novartis Investigative Site
Freiburg im Breisgau
Novartis Investigative Site
Giessen
Novartis Investigative Site
Hamburg
Novartis Investigative Site
Heidelberg
Novartis Investigative Site
Karlsruhe
Novartis Investigative Site
Kiel
Novartis Investigative Site
Landshut
Novartis Investigative Site
Leipzig
Novartis Investigative Site
Marburg
Novartis Investigative Site
Mühlheim
Novartis Investigative Site
München
Novartis Investigative Site
Münster
Novartis Investigative Site
Nuremberg
Novartis Investigative Site
Postdam
Novartis Investigative Site
Recklinghausen
Novartis Investigative Site
Regensburg
Novartis Investigative Site
Rosenheim
Novartis Investigative Site
Siegburg
Novartis Investigative Site
Stuttgart
Novartis Investigative Site
Ulm
Novartis Investigative Site
Würzburg
About this study
Official title: A 12-month, Two-armed, Randomized, Double-masked, Multicenter, Phase IIIb Study Assessing the Efficacy and Safety of Laser Photocoagulation as Adjunctive to Ranibizumab Intravitreal Injections vs. Laser Photocoagulation Monotherapy in Patients With Visual Impairment Due to Diabetic Macular Edema Followed by a 12 Month Follow up Period
This study was designed to confirm the efficacy and safety of laser photocoagulation as adjunctive therapy to ranibizumab 0.5 mg versus laser monotherapy in patients with visual impairment due to Diabetic Macular Edema. A subgroup of patients with Proliferative Diabetic Retinopathy were included to evaluate the efficacy and safety of laser photocoagulation as adjunctive therapy to ranibizumab 0.5 mg versus laser monotherapy in this population.
- Being tested
- Active laser photocoagulation, Sham injections, Ranibizumab 0.5 mg
- Keywords
- Diabetic macular edema, DME, Proliferative diabetic retinopathy, PDR, ranibizumab, laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active laser photocoagulationProcedure or surgery
Active laser photocoagulation procedure at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.
Sham injectionsDrug
Sham intravitreal injections at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment.
Ranibizumab 0.5 mgDrug
Ranibizumab 0.5 mg/0.05 ml intravitreal injection at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment.
| Study group | Role | What they receive |
|---|---|---|
| Active laser photocoagulation and ranibizumab | Experimental | Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.
Ranibizumab intravitreal injection given at baseline, at 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment. Receives: Procedure: Active laser photocoagulation; Drug: Ranibizumab 0.5 mg |
| Active laser photocoagulation and sham injection | Active comparator | Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.
Sham intravitreal injection given at baseline, at 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment. Receives: Procedure: Active laser photocoagulation; Drug: Sham injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Best-Corrected Visual Acuity (BCVA) From Baseline to Month 12
Mean change in Best-Corrected Visual Acuity (BCVA) letters at 12 months compared to baseline was measured using Visual acuity (VA). VA accounts for the number of letters a participant can see using Early Treatment Diabetic Retinopathy Study (EDTRS)-like visual acuity testing charts, from a sitting position at a testing distance of 4 meters. BCVA means that the participant's refraction is already taken into account when VA is determined. A higher BCVA number at 12 months in reference to baseline indicates improved BCVA.
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 posted27 May 2010 (estimated)
- Study startJun 2010
- Primary completionJul 2011
- Study completionJul 2011
Why it stopped: European drug approval.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Visual Impairment Due to Diabetic Macular EdemaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01131585
- Sponsor's protocol ID
- CRFB002DDE13
- Other IDs
- 2010-018852-29
- Acronym
- RELATION
- Status last verified
- Aug 2012
- First submitted
- 25 May 2010
- Last updated
- 30 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-month, Two-armed, Randomized, Double-masked, Multicenter, Phase IIIb Study Assessing the Efficacy and Safety of Laser Photocoagulation as Adjunctive to Ranibizumab Intravitreal Injections vs. Laser Photocoagulation Monotherapy in Patients With Visual Impairment Due to Diabetic Macular Edema Followed by a 12 Month Follow up Period
- ClinicalTrials.gov ID
- NCT01131585
- Acronym / sponsor ID
- RELATION / CRFB002DDE13
- Keywords
- Diabetic macular edema, DME, Proliferative diabetic retinopathy, PDR, ranibizumab, laser
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: European drug approval.
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 27 May 2010 (estimated)
- Results
- Posted 17 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was designed to confirm the efficacy and safety of laser photocoagulation as adjunctive therapy to ranibizumab 0.5 mg versus laser monotherapy in patients with visual impairment due to Diabetic Macular Edema. A subgroup of patients with Proliferative Diabetic Retinopathy were included to evaluate the efficacy and safety of laser photocoagulation as adjunctive therapy to ranibizumab 0.5 mg versus laser monotherapy in this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active laser photocoagulation and ranibizumab | Experimental | Procedure: Active laser photocoagulation, Drug: Ranibizumab 0.5 mgActive laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment. Ranibizumab intravitreal injection given at baseline, at 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment. |
| Active laser photocoagulation and sham injection | Active comparator | Procedure: Active laser photocoagulation, Drug: Sham injectionsActive laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment. Sham intravitreal injection given at baseline, at 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Visual acuity impairment caused by macular edema in at least one eye
- Type 1 or type 2 diabetes mellitus
- Stable medication of diabetes in past 3 month
Key exclusion criteria (5 listed)
- Patients with uncontrolled systemic or ocular diseases
- Laser photocoagulation in the study eye for the last 3 months
- Any history of any intraocular surgery in the study eye within the past 3 months
- Blood pressure > 160/100 mmHg
- Other protocol defined inclusion/exclusion criteria may apply
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 |
|---|---|---|
| Active laser photocoagulationActive laser photocoagulation procedure at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment. | Procedure or surgery | Active laser photocoagulation and ranibizumab, Active laser photocoagulation and sham injection |
| Sham injectionsSham intravitreal injections at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment. | Drug | Active laser photocoagulation and sham injection |
| Ranibizumab 0.5 mgRanibizumab 0.5 mg/0.05 ml intravitreal injection at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment. | Drug | Active laser photocoagulation and ranibizumab |
Primary outcome
Change in Best-Corrected Visual Acuity (BCVA) From Baseline to Month 12
Time frame: 12 months
Mean change in Best-Corrected Visual Acuity (BCVA) letters at 12 months compared to baseline was measured using Visual acuity (VA). VA accounts for the number of letters a participant can see using Early Treatment Diabetic Retinopathy Study (EDTRS)-like visual acuity testing charts, from a sitting position at a testing distance of 4 meters. BCVA means that the participant's refraction is already taken into account when VA is determined. A higher BCVA number at 12 months in reference to baseline indicates improved BCVA.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Click here for more information about this study:Link provided by the sponsor.
Related trials for Visual Impairment Due to Diabetic Macular Edema
Active, not recruitingObservational study
The SPECTRUM Study: An Observational Study to Learn More About How Well Aflibercept 8 mg Works in Treating Visual Impairment Due to Neovascular Age-related Macular Degeneration or Diabetic Macula Edema
Visual Impairment, Neovascular Age-related Macular Degeneration (nAMD)
Active, not recruitingPhase 3
A 3-month Study to Compare the Safety of ONS-5010 in Vials Versus Pre-filled Syringe in Subjects With Visual Impairment Due to Retinal Disorders
Age-Related Macular Degeneration, Neovascular Age-related Macular Degeneration
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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Active laser photocoagulation and Ranibizumab 0.5 mg in people with Visual Impairment Due to Diabetic Macular Edema, run by Novartis Pharmaceuticals at 34 sites in Germany.
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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 30 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in Germany. 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 phase mean?
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?
Yes. Results are posted in the registry (first posted 17 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Best-Corrected Visual Acuity (BCVA) From Baseline to Month 12 (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 30 Aug 2012.