Diabetic Macular EdemaPhase 2RED-ESNCT00901186
Efficacy and Safety of Ranibizumab (Intravitreal Injections) Versus Laser Treatment in Patients With Visual Impairment Due to Diabetic Macular Edema
A Phase 2 study testing RFB002 and Laser photocoagulation in people with Diabetic Macular Edema and Visual Impairment, run by Novartis Pharmaceuticals at 17 sites in Spain.
Trial summary
This study will assess the efficacy and safety of ranibizumab (intravitreal injections) versus laser treatment 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
- Diabetic Macular Edema, Visual Impairment
- What is being tested?
- RFB002 and Laser photocoagulation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 17 sitesSpain
- Study dates
- Nov 2009to Aug 2012
- Phase
- Phase 2
- 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
- Diabetes mellitus 1 or 2, HbA1c < 11.0%, With: Clinically significant Diabetic Macular Edema in at least one eye.
- Previous treatment with macular photocoagulation only should be considered if the investigator believes that the study eye may possibly benefit from additional photocoagulation.
- Best corrected visual acuity score between 78 and 25 letters (Early Treatment Diabetic Retinopathy Study- ETDRS Chart - 4 meters).
- Central foveal thickness >250µm (Optical Coherence Tomography).
- Diabetes medication stable in the 3 months prior.
Who cannot join
- In the study eye:
- Active intraocular inflammation.
- Any active infection.
- History of uveitis.
- Structural damage within 500 microns of the center of the macula.
- Neovascularization of the iris.
- Uncontrolled glaucoma in either eye (Intraocular Pressure > 24 mmHg).
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Spain17 sites
Novartis Investigative Site
Almería, Andalusia, 04009
Novartis Investigative Site
Barakaldo, Basque Country, 48903
Novartis Investigative Site
Barcelona, Barcelona, 08021
Novartis Investigative Site
Barcelona, Barcelona, 08025
Novartis Investigative Site
Cadiz, Andalusia, 11009
Novartis Investigative Site
L'Hospitalet de Llobregat, Barcelona, 08907
Novartis Investigative Site
Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, 35016
Novartis Investigative Site
Madrid, Madrid, 28035
Novartis Investigative Site
Madrid, Madrid
Novartis Investigative Site
Madrid, 28002
Novartis Investigative Site
Málaga, Andalusia, 29010
Novartis Investigative Site
Mallorca, Balearic Islands, 07198
Novartis Investigative Site
Pamplona, Navarre, 31080
Novartis Investigative Site
San Cristóbal de La Laguna, Las Palmas de Gran Canaria, 38320
Novartis Investigative Site
Terrassa, Catalonia, 08221
Novartis Investigative Site
Valencia, Valencia, 46026
Novartis Investigative Site
Valladolid, Castille and León, 47011
About this study
Official title: A Randomized, Open Label, Multicenter, Laser-controlled Phase II Study Assessing the Efficacy and Safety of Ranibizumab (Intravitreal Injections) vs. Laser Treatment in Patients With Visual Impairment Due to Diabetic Macular Edema
This study will assess the efficacy and safety of ranibizumab (intravitreal injections) versus laser treatment in patients with visual impairment due to diabetic macular edema.
- Conditions
- Diabetic Macular Edema, Visual Impairment
- Being tested
- RFB002, Laser photocoagulation
- Keywords
- Diabetic Macular Edema, Ranibizumab, Laser Treatment, Visual impairment
- Medical subject headings
- Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RFB002Drug
Also called Ranibizumab
0.5 mg
Laser photocoagulationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| RFB002 | Experimental | RFB002 0.5 mg was administered to the study eye with a single monthly intravitreal injection on day 1, day 30 and day 60. After day 90, if stable vision was not achieved, a monthly injection of RFB002 0.5 mg was administered until stable vision was achieved. Receives: Drug: RFB002 |
| Laser photocoagulation | Active comparator | At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4. Receives: Procedure: Laser photocoagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA)
Visual acuity (VA) was assessed on the study eye during every study visit using best correction determined from protocol refraction. VA measurements were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters.
Measured: Baseline, 12 months
Secondary outcomes (5)
Percentage of Participants With Improvement in BCVA
Visual acuity (VA) was assessed on the study eye during every study visit using best correction determined from protocol refraction. VA measurements were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters.
Measured: 12 months
Evolution of Mean Change From Baseline in BCVA by Study Visit
Visual acuity (VA) was assessed on the study eye during every study visit using best correction determined from protocol refraction. VA measurements were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters.
Measured: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Percentage of Participants With VA > 73 Letters With Ranibizumab (0.5 mg) vs Laser.
VA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters.
Measured: 12 months
Mean Change From Baseline in Central Retinal Thickness (CRT) by Study Visit
CRT was assessed by Optical Coherence Tomography (OCT).
Measured: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Percentage of CRT Change From Baseline by Study Visit
CRT was assessed by Optical Coherence Tomography (OCT).
Measured: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2009 (estimated)
- Study startNov 2009
- Primary completionAug 2012
- Study completionAug 2012
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 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis PharmaceuticalsNovartis Pharmaceuticals, Study chair, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00901186
- Sponsor's protocol ID
- CRFB002DES01
- Other IDs
- 2009-010825-37, 2009
- Acronym
- RED-ES
- Status last verified
- Jul 2014
- First submitted
- 11 May 2009
- Last updated
- 3 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Multicenter, Laser-controlled Phase II Study Assessing the Efficacy and Safety of Ranibizumab (Intravitreal Injections) vs. Laser Treatment in Patients With Visual Impairment Due to Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT00901186
- Acronym / sponsor ID
- RED-ES / CRFB002DES01
- Conditions
- Diabetic Macular Edema, Visual Impairment
- Keywords
- Diabetic Macular Edema, Ranibizumab, Laser Treatment, Visual impairment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 13 May 2009 (estimated)
- Results
- Posted 3 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the efficacy and safety of ranibizumab (intravitreal injections) versus laser treatment in patients with visual impairment due to diabetic macular edema.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RFB002 | Experimental | Drug: RFB002RFB002 0.5 mg was administered to the study eye with a single monthly intravitreal injection on day 1, day 30 and day 60. After day 90, if stable vision was not achieved, a monthly injection of RFB002 0.5 mg was administered until stable vision was achieved. |
| Laser photocoagulation | Active comparator | Procedure: Laser photocoagulationAt least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diabetes mellitus 1 or 2, HbA1c < 11.0%, With: Clinically significant Diabetic Macular Edema in at least one eye.
- Previous treatment with macular photocoagulation only should be considered if the investigator believes that the study eye may possibly benefit from additional photocoagulation.
- Best corrected visual acuity score between 78 and 25 letters (Early Treatment Diabetic Retinopathy Study- ETDRS Chart - 4 meters).
- Central foveal thickness >250µm (Optical Coherence Tomography).
- Diabetes medication stable in the 3 months prior.
Key exclusion criteria (8 listed)
- Active intraocular inflammation.
- Any active infection.
- History of uveitis.
- Structural damage within 500 microns of the center of the macula.
- Neovascularization of the iris.
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 |
|---|---|---|
| RFB002Also: Ranibizumab0.5 mg | Drug | RFB002 |
| Laser photocoagulation | Procedure or surgery | Laser photocoagulation |
Primary outcome
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA)
Time frame: Baseline, 12 months
Visual acuity (VA) was assessed on the study eye during every study visit using best correction determined from protocol refraction. VA measurements were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters.
5 secondary outcomes
Percentage of Participants With Improvement in BCVA
Time frame: 12 months
Evolution of Mean Change From Baseline in BCVA by Study Visit
Time frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Percentage of Participants With VA > 73 Letters With Ranibizumab (0.5 mg) vs Laser.
Time frame: 12 months
Mean Change From Baseline in Central Retinal Thickness (CRT) by Study Visit
Time frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Percentage of CRT Change From Baseline by Study Visit
Time frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
Novartis Pharmaceuticals study chair
Novartis
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RFB002 and Laser photocoagulation in people with Diabetic Macular Edema and Visual Impairment, run by Novartis Pharmaceuticals at 17 sites in Spain.
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 8 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: finished, as of the sponsor's last update on 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Spain. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 3 Jul 2014). 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?
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) (time frame: Baseline, 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 3 Mar 2017.