Ranibizumab Treatment of Diabetic Macular Oedema With Bimonthly Monitoring After a Phase of Initial Treatment (RELIGHT)
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ClinicalTrials.gov Identifier: NCT01257815 |
Recruitment Status :
Completed
First Posted : December 10, 2010
Last Update Posted : September 30, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetic Retinopathy Macular Oedema | Drug: Ranibizumab | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 111 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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. |
Study Start Date : | January 2011 |
Actual Primary Completion Date : | April 2013 |
Actual Study Completion Date : | April 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: Ranibizumab 0.5mg |
Drug: Ranibizumab |
- The change in mean Best Corrected Visual Acuity (BCVA) [ Time Frame: Baseline to 12 months ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01257815
United Kingdom | |
Novartis Investigative Site | |
Torquay, Devon,, United Kingdom, TQ2 7AA | |
Novartis Investigative Site | |
Ayr, United Kingdom, KA6 6DX | |
Novartis Investigative Site | |
Belfast, United Kingdom, BT12 6BA | |
Novartis Investigative Site | |
Birmingham, United Kingdom, B9 5SS | |
Novartis Investigative Site | |
Cardiff,, United Kingdom, CF14 4XW | |
Novartis Investigative Site | |
Colchester, United Kingdom, CO3 3NB | |
Novartis Investigative Site | |
Fife, United Kingdom, KY12 OSU | |
Novartis Investigative Site | |
Great Yarmouth, United Kingdom, NR31 6LA | |
Novartis Investigative Site | |
Hull, United Kingdom, HU3 2JZ | |
Novartis Investigative Site | |
Liverpool, United Kingdom, L7 8XP | |
Novartis Investigative Site | |
London, United Kingdom, E11 1NR | |
Novartis Investigative Site | |
London, United Kingdom, SE5 9RS | |
Novartis Investigative Site | |
Rugby, United Kingdom, CV22 5PX | |
Novartis Investigative Site | |
Uxbridge, United Kingdom, UB8 3NN | |
Novartis Investigative Site | |
York, United Kingdom, YO31 8HE |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT01257815 |
Other Study ID Numbers: |
CRFB002DGB14 2010-022616-39 ( EudraCT Number ) |
First Posted: | December 10, 2010 Key Record Dates |
Last Update Posted: | September 30, 2014 |
Last Verified: | September 2014 |
Diabetes mellitus Diabetic retinopathy Macular oedema Visual acuity |
Macular Edema Retinal Diseases Diabetic Retinopathy Edema Macular Degeneration Retinal Degeneration Eye Diseases Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases |
Diabetes Complications Diabetes Mellitus Endocrine System Diseases Ranibizumab Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents |