Diabetic RetinopathyPhase 4RELIGHTNCT01257815
Ranibizumab Treatment of Diabetic Macular Oedema With Bimonthly Monitoring After a Phase of Initial Treatment
A Phase 4 study testing Ranibizumab in people with Diabetic Retinopathy and Macular Oedema, run by Novartis Pharmaceuticals at 15 sites in United Kingdom.
Trial summary
This study evaluates a new investigational treatment regimen of three consecutive monthly doses of ranibizumab followed by an as-needed treatment regimen, with monthly follow-up for the first three months then two-monthly follow-up until 18 months in patients with visual impairment due to diabetic macular oedema.The… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy, Macular Oedema
- What is being tested?
- Ranibizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 15 sitesUnited Kingdom
- Study dates
- Jan 2011to Apr 2013
- Phase
- Phase 4
- 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
Who may be able to join
- Patients with Type 1 or Type 2 diabetes mellitus.
- Patients with visual impairment due to focal or diffuse diabetic macular oedema (DMO), and not other causes, in at least one eye who are eligible for laser treatment in the opinion of the investigator.
- Best Corrected Visual Acuity between 78 and 24 letters in the study eye using Early Treatment Diabetic Retinopathy Study (ETDRS)-like grading charts (approximate Snellen equivalent of 20/32 to 20/320).
- Increased central retinal thickness which, in the opinion of the investigator, is due to DMO.
Who cannot join
- Concomitant conditions in the study eye that could prevent the improvement of visual acuity on study treatment.
- Active intraocular inflammation (grade trace or above) or infection in either eye at enrollment.
- History of uveitis in either eye at any time.
- Structural damage within 0.5 disc diameters of the centre of the macular in the study eye likely to preclude improvement in visual acuity following resolution of macular oedema.
- Planned medical or surgical intervention during the 18-month study period.
- Uncontrolled glaucoma in either eye at screening.
Show all 12Show fewer
- Blood pressure systolic > 160 mmHg or diastolic > 100 mmHg at screening.
- Ocular conditions in the study eye that require chronic concomitant therapy with topical ocular or systemically administered corticosteroids.
- History of acute thromboembolic event within 4 months of screening.
- Untreated diabetes mellitus.
- Evidence of advanced, severe or unstable concomitant disease or its treatment which may interfere with evaluations or put the patient at special risk.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United Kingdom15 sites
Novartis Investigative Site
Ayr, KA6 6DX
Novartis Investigative Site
Belfast, BT12 6BA
Novartis Investigative Site
Birmingham, B9 5SS
Novartis Investigative Site
Cardiff, CF14 4XW
Novartis Investigative Site
Colchester, CO3 3NB
Novartis Investigative Site
Fife, KY12 OSU
Novartis Investigative Site
Great Yarmouth, NR31 6LA
Novartis Investigative Site
Hull, Hull, HU3 2JZ
Novartis Investigative Site
Liverpool, L7 8XP
Novartis Investigative Site
London, E11 1NR
Novartis Investigative Site
London, SE5 9RS
Novartis Investigative Site
Rugby, CV22 5PX
Novartis Investigative Site
Torquay, Devon,, TQ2 7AA
Novartis Investigative Site
Uxbridge, UB8 3NN
Novartis Investigative Site
York, YO31 8HE
About this study
Official title: Ranibizumab Treatment of Diabetic Macular Oedema With Bimonthly Monitoring After a Phase of Initial Treatment. A UK, 18-month, Prospective, Open-label, Multicentre, Single-arm, Phase IIIb Study With 12-month Primary Endpoint, Assessing the Efficacy and Safety of Ranibizumab in Patients With Visual Impairment Due to Diabetic Macular Oedema.
This study evaluates a new investigational treatment regimen of three consecutive monthly doses of ranibizumab followed by an as-needed treatment regimen, with monthly follow-up for the first three months then two-monthly follow-up until 18 months in patients with visual impairment due to diabetic macular oedema.The aim of the study is to determine if this treatment regimen is effective and safe in these patients.
- Conditions
- Diabetic Retinopathy, Macular Oedema
- Being tested
- Ranibizumab
- Keywords
- Diabetes mellitus, Diabetic retinopathy, Macular oedema, Visual acuity
- Medical subject headings
- Diabetic Retinopathy, Macular Edema, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanibizumabDrug
| Study group | Role | What they receive |
|---|---|---|
| Ranibizumab 0.5mg | Experimental | Not described Receives: Drug: Ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in mean Best Corrected Visual Acuity (BCVA)
Measured: Baseline to 12 months
Secondary outcomes (5)
The change in mean Best Corrected Visual Acuity (BCVA)
Measured: Baseline to 18 months
Occurrence of ocular and systemic adverse events
Measured: Baseline to 18 months
Time course of changes in BCVA
Measured: From 6 to 12 and 18 months
Time course of changes in central retinal thickness
Measured: From baseline and 6 months to 12 and 18 months
Proportion of patients with 10 and 15 letter improvement or loss in BCVA
Measured: From baseline to 12 and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic RetinopathyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 111 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
- NCT01257815
- Sponsor's protocol ID
- CRFB002DGB14
- Other IDs
- 2010-022616-39
- Acronym
- RELIGHT
- Status last verified
- Sep 2014
- First submitted
- 8 Dec 2010
- Last updated
- 30 Sep 2014
- Results posted
- No
Publications
Pearce I, Banerjee S, Burton BJ, Chakravarthy U, Downey L, Gale RP, Gibson J, Pagliarini S, Patel J, Sivaprasad S, Andrews C, Brittain C, Warburton J; RELIGHT Study Group. Ranibizumab 0.5 mg for Diabetic Macular Edema with Bimonthly Monitoring after a Phase of Initial Treatment: 18-Month, Multicenter, Phase IIIB RELIGHT Study. Ophthalmology. 2015 Sep;122(9):1811-9. doi: 10.1016/j.ophtha.2015.05.038. Epub 2015 Jul 3.
PubMed 26150052
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ranibizumab Treatment of Diabetic Macular Oedema With Bimonthly Monitoring After a Phase of Initial Treatment. A UK, 18-month, Prospective, Open-label, Multicentre, Single-arm, Phase IIIb Study With 12-month Primary Endpoint, Assessing the Efficacy and Safety of Ranibizumab in Patients With Visual Impairment Due to Diabetic Macular Oedema.
- ClinicalTrials.gov ID
- NCT01257815
- Acronym / sponsor ID
- RELIGHT / CRFB002DGB14
- Conditions
- Diabetic Retinopathy, Macular Oedema
- Keywords
- Diabetes mellitus, Diabetic retinopathy, Macular oedema, Visual acuity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 10 Dec 2010 (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 evaluates a new investigational treatment regimen of three consecutive monthly doses of ranibizumab followed by an as-needed treatment regimen, with monthly follow-up for the first three months then two-monthly follow-up until 18 months in patients with visual impairment due to diabetic macular oedema.The aim of the study is to determine if this treatment regimen is effective and safe in these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ranibizumab 0.5mg | Experimental | Drug: Ranibizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with Type 1 or Type 2 diabetes mellitus.
- Patients with visual impairment due to focal or diffuse diabetic macular oedema (DMO), and not other causes, in at least one eye who are eligible for laser treatment in the opinion of the investigator.
- Best Corrected Visual Acuity between 78 and 24 letters in the study eye using Early Treatment Diabetic Retinopathy Study (ETDRS)-like grading charts (approximate Snellen equivalent of 20/32 to 20/320).
- Increased central retinal thickness which, in the opinion of the investigator, is due to DMO.
Key exclusion criteria (12 listed)
- Concomitant conditions in the study eye that could prevent the improvement of visual acuity on study treatment.
- Active intraocular inflammation (grade trace or above) or infection in either eye at enrollment.
- History of uveitis in either eye at any time.
- Structural damage within 0.5 disc diameters of the centre of the macular in the study eye likely to preclude improvement in visual acuity following resolution of macular oedema.
- Planned medical or surgical intervention during the 18-month study period.
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 |
|---|---|---|
| Ranibizumab | Drug | Ranibizumab 0.5mg |
Primary outcome
The change in mean Best Corrected Visual Acuity (BCVA)
Time frame: Baseline to 12 months
5 secondary outcomes
The change in mean Best Corrected Visual Acuity (BCVA)
Time frame: Baseline to 18 months
Occurrence of ocular and systemic adverse events
Time frame: Baseline to 18 months
Time course of changes in BCVA
Time frame: From 6 to 12 and 18 months
Time course of changes in central retinal thickness
Time frame: From baseline and 6 months to 12 and 18 months
Proportion of patients with 10 and 15 letter improvement or loss in BCVA
Time frame: From baseline to 12 and 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2014.
- Derived from this study: PubMed 26150052Pearce I, Banerjee S, Burton BJ, Chakravarthy U, Downey L, Gale RP, Gibson J, Pagliarini S, Patel J, Sivaprasad S, Andrews C, Brittain C, Warburton J; RELIGHT Study Group. Ranibizumab 0.5 mg for Diabetic Macular Edema with Bimonthly Monitoring after a Phase of Initial Treatment: 18-Month, Multicenter, Phase IIIB RELIGHT Study. Ophthalmology. 2015 Sep;122(9):1811-9. doi: 10.1016/j.ophtha.2015.05.038. Epub 2015 Jul 3.
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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
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ranibizumab in people with Diabetic Retinopathy and Macular Oedema, run by Novartis Pharmaceuticals at 15 sites in United Kingdom.
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 4 inclusion and 12 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 30 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United Kingdom. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The change in mean Best Corrected Visual Acuity (BCVA) (time frame: Baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01257815, which also lists 1 linked publication.
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 Sep 2014.