Lucentis (Ranibizumab) in Diabetic Macular Oedema: a Treatment Evaluation (LUCIDATE)
Primary Purpose
Diabetic Retinopathy
Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Ranibizumab
Modified ETDRS laser
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Retinopathy focused on measuring Diabetes Mellitus, Diabetes Complications, Retinal Diseases, Edema, Endothelial Growth Factors, Monoclonal Antibodies, Ranibizumab, Laser therapy
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of diabetes mellitus (type 1 or type 2)
- Retinal thickening due to diabetic macular oedema involving the centre of the macula and OCT central subfield ≥ 300 microns
- Best corrected visual acuity in the study eye between 55 and 79 ETDRS letters at 1 metre (Snellen equivalent ≥ 6/24 and ≤ 6/9)
- Media clarity, pupillary dilation, and subject cooperation sufficient for adequate fundus photographs
- Intraocular pressure less than 30 mmHg
- Ability to return for study visits
- Visual acuity in fellow eye ≥ 2/60
- Fellow eye has received no anti-VEGF treatment within the past 3 months and no expectation of such treatment in next 12 months
- No previous laser within 3 months of randomisation
- Ability to give informed consent throughout the duration of the study
Exclusion Criteria:
- Macular ischaemia
- Macular oedema from a cause other than diabetic macular oedema
- Co-existent ocular disease
- Presence of an ocular condition such that visual acuity would not improve from resolution of macular oedema
- Presence of an ocular condition that might affect macular oedema or alter visual acuity during the course of the study
- A substantial cataract that is likely to be decreasing visual acuity by 3 lines or more
- History of treatment for diabetic macular oedema at any time in the past 3 months
- History of panretinal scatter photocoagulation (PRP) within 3 months prior to randomisation
- Anticipated need for PRP in the 6 months following randomisation.
- Proliferative diabetic retinopathy in the study eye.
- A condition that, in the opinion of the investigator, would preclude participation in the study.
- Haemoglobin A1c > 11.0 %
- A past medical history of significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant
- Blood pressure >170/100 mmHg
- Myocardial infarction, other cardiac event requiring hospitalisation, stroke, transient ischaemic attack, or treatment for acute congestive heart failure within 6 months prior to randomisation
- Major surgery within 28 days prior to randomisation or major surgery planned during the next 12 months at baseline
- Participation in an investigational trial within 30 days of randomisation that involved treatment with any drug that has not received regulatory approval at the time of study entry. Note: subjects cannot receive another investigational drug while participating in the study
- Systemic anti-VEGF or pro-VEGF treatment within 3 months prior to randomisation
- Pregnant or lactating women or women intending to become pregnant within the study period including 3 months after study cessation
- History of major ocular surgery (including cataract extraction, scleral buckle, any intraocular surgery) within prior 3 months or anticipated within the next 6 months following randomisation.
- Aphakia
- Uncontrolled glaucoma
- External ocular infection, including conjunctivitis, chalazion, or severe blepharitis
- Known allergy to fluorescein dye or to any component of the study drug
- Fertile male unwilling to use contraception for the duration of the study
Sites / Locations
- Moorfields Eye Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ranibizumab
Laser
Arm Description
Intravitreal injection of ranibizumab
Modified ETDRS laser
Outcomes
Primary Outcome Measures
Functional and anatomical change in the retina
This is an exploratory study. The primary outcome measure is the change in retinal function and anatomy at 48 weeks compared to baseline, as assessed by fluorescein angiography, microperimetry and electrophysiological testing.
Secondary Outcome Measures
Mean ETDRS acuity
Difference in mean ETDRS visual acuity between the two study arms.
OCT macular thickness
Difference in mean OCT central retinal thickness between the two study arms.
Full Information
NCT ID
NCT01223612
First Posted
October 18, 2010
Last Updated
September 7, 2020
Sponsor
Moorfields Eye Hospital NHS Foundation Trust
Collaborators
Novartis
1. Study Identification
Unique Protocol Identification Number
NCT01223612
Brief Title
Lucentis (Ranibizumab) in Diabetic Macular Oedema: a Treatment Evaluation
Acronym
LUCIDATE
Official Title
Diabetic Macula Oedema. A Prospective Randomised Study Comparing the Detailed Functional and Anatomical Changes of Repeated Pan Anti-VEGF Therapy With Ranibizumab Versus Conventional Macular Laser Therapy.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Moorfields Eye Hospital NHS Foundation Trust
Collaborators
Novartis
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This exploratory study will compare the effects of ranibizumab treatment with conventional macular laser therapy for patients with diabetic macular oedema.
The study hypothesises that treatment with ranibizumab may be superior to laser treatment in terms of improving vision and decreasing retinal thickness.
Patients will be randomised to receive either repeated injections of ranibizumab every 4 weeks for 48 weeks or macular laser therapy every 12 weeks for 48 weeks.
At baseline, and then at 12, 24 and 48 weeks, patients will undergo detailed testing to provide information on the structure and function of the retina with both of these treatments.
Detailed Description
Adult patients with centre-involving diabetic macular oedema will be recruited to this single-centre study. Patients will undergo detailed baseline evaluation which will include:
vision testing
optical coherence tomography scanning
fundus fluorescein angiography
microperimetry
colour contrast sensitivity testing
electrophysiological testing
Patients will be randomised 2:1 to receive either ranibizumab intravitreal injection 4-weekly for 48 weeks or modified ETDRS macular laser therapy 12-weekly for 48 weeks.
Both groups of patients will return at 12, 24 and 48 weeks for repeat testing of the parameters evaluated at baseline.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy
Keywords
Diabetes Mellitus, Diabetes Complications, Retinal Diseases, Edema, Endothelial Growth Factors, Monoclonal Antibodies, Ranibizumab, Laser therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ranibizumab
Arm Type
Experimental
Arm Description
Intravitreal injection of ranibizumab
Arm Title
Laser
Arm Type
Active Comparator
Arm Description
Modified ETDRS laser
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
Intravitreal injection of 0.5mg in 0.05ml. One injection at baseline, 4 and 8 weeks then four-weekly as required to 44 weeks.
Intervention Type
Procedure
Intervention Name(s)
Modified ETDRS laser
Other Intervention Name(s)
Argon laser photocoagulation
Intervention Description
Argon laser therapy to the macula in accordance with the modified ETDRS protocol at baseline, 12, 24 and 36 weeks.
Primary Outcome Measure Information:
Title
Functional and anatomical change in the retina
Description
This is an exploratory study. The primary outcome measure is the change in retinal function and anatomy at 48 weeks compared to baseline, as assessed by fluorescein angiography, microperimetry and electrophysiological testing.
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Mean ETDRS acuity
Description
Difference in mean ETDRS visual acuity between the two study arms.
Time Frame
48 weeks
Title
OCT macular thickness
Description
Difference in mean OCT central retinal thickness between the two study arms.
Time Frame
48 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of diabetes mellitus (type 1 or type 2)
Retinal thickening due to diabetic macular oedema involving the centre of the macula and OCT central subfield ≥ 300 microns
Best corrected visual acuity in the study eye between 55 and 79 ETDRS letters at 1 metre (Snellen equivalent ≥ 6/24 and ≤ 6/9)
Media clarity, pupillary dilation, and subject cooperation sufficient for adequate fundus photographs
Intraocular pressure less than 30 mmHg
Ability to return for study visits
Visual acuity in fellow eye ≥ 2/60
Fellow eye has received no anti-VEGF treatment within the past 3 months and no expectation of such treatment in next 12 months
No previous laser within 3 months of randomisation
Ability to give informed consent throughout the duration of the study
Exclusion Criteria:
Macular ischaemia
Macular oedema from a cause other than diabetic macular oedema
Co-existent ocular disease
Presence of an ocular condition such that visual acuity would not improve from resolution of macular oedema
Presence of an ocular condition that might affect macular oedema or alter visual acuity during the course of the study
A substantial cataract that is likely to be decreasing visual acuity by 3 lines or more
History of treatment for diabetic macular oedema at any time in the past 3 months
History of panretinal scatter photocoagulation (PRP) within 3 months prior to randomisation
Anticipated need for PRP in the 6 months following randomisation.
Proliferative diabetic retinopathy in the study eye.
A condition that, in the opinion of the investigator, would preclude participation in the study.
Haemoglobin A1c > 11.0 %
A past medical history of significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant
Blood pressure >170/100 mmHg
Myocardial infarction, other cardiac event requiring hospitalisation, stroke, transient ischaemic attack, or treatment for acute congestive heart failure within 6 months prior to randomisation
Major surgery within 28 days prior to randomisation or major surgery planned during the next 12 months at baseline
Participation in an investigational trial within 30 days of randomisation that involved treatment with any drug that has not received regulatory approval at the time of study entry. Note: subjects cannot receive another investigational drug while participating in the study
Systemic anti-VEGF or pro-VEGF treatment within 3 months prior to randomisation
Pregnant or lactating women or women intending to become pregnant within the study period including 3 months after study cessation
History of major ocular surgery (including cataract extraction, scleral buckle, any intraocular surgery) within prior 3 months or anticipated within the next 6 months following randomisation.
Aphakia
Uncontrolled glaucoma
External ocular infection, including conjunctivitis, chalazion, or severe blepharitis
Known allergy to fluorescein dye or to any component of the study drug
Fertile male unwilling to use contraception for the duration of the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip G Hykin, FRCS FRCOphth
Organizational Affiliation
Moorfields Eye Hospital NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Moorfields Eye Hospital
City
London
ZIP/Postal Code
EC1V 2PD
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Lucentis (Ranibizumab) in Diabetic Macular Oedema: a Treatment Evaluation
We'll reach out to this number within 24 hrs