Diabetic RetinopathyPhase 4LUCIDATENCT01223612
Lucentis (Ranibizumab) in Diabetic Macular Oedema: a Treatment Evaluation
A Phase 4 study testing Ranibizumab and Modified ETDRS laser in people with Diabetic Retinopathy, run by Moorfields Eye Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- Ranibizumab and Modified ETDRS laser
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2010to Jul 2012
- 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
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Diabetic Retinopathy
- Being tested
- Ranibizumab, Modified ETDRS laser
- Keywords
- Diabetes Mellitus, Diabetes Complications, Retinal Diseases, Edema, Endothelial Growth Factors, Monoclonal Antibodies, Ranibizumab, Laser therapy
- Medical subject headings
- Diabetic Retinopathy, Diabetes Mellitus, Diabetes Complications, Retinal Diseases, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanibizumabDrug
Also called Lucentis
Intravitreal injection of 0.5mg in 0.05ml. One injection at baseline, 4 and 8 weeks then four-weekly as required to 44 weeks.
Modified ETDRS laserProcedure or surgery
Also called Argon laser photocoagulation
Argon laser therapy to the macula in accordance with the modified ETDRS protocol at baseline, 12, 24 and 36 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Ranibizumab | Experimental | Intravitreal injection of ranibizumab Receives: Drug: Ranibizumab |
| Laser | Active comparator | Modified ETDRS laser Receives: Procedure: Modified ETDRS laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 weeks
Secondary outcomes (2)
Mean ETDRS acuity
Difference in mean ETDRS visual acuity between the two study arms.
Measured: 48 weeks
OCT macular thickness
Difference in mean OCT central retinal thickness between the two study arms.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- Philip G Hykin, FRCS FRCOphth, Principal investigator, Moorfields Eye Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01223612
- Sponsor's protocol ID
- HYKP1015
- Acronym
- LUCIDATE
- Status last verified
- Sep 2020
- First submitted
- 18 Oct 2010
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01223612
- Acronym / sponsor ID
- LUCIDATE / HYKP1015
- Conditions
- Diabetic Retinopathy
- Keywords
- Diabetes Mellitus, Diabetes Complications, Retinal Diseases, Edema, Endothelial Growth Factors, Monoclonal Antibodies, Ranibizumab, Laser therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Oct 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 19 Oct 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ranibizumab | Experimental | Drug: RanibizumabIntravitreal injection of ranibizumab |
| Laser | Active comparator | Procedure: Modified ETDRS laserModified ETDRS laser |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (25 listed)
- 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
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 |
|---|---|---|
| RanibizumabAlso: LucentisIntravitreal injection of 0.5mg in 0.05ml. One injection at baseline, 4 and 8 weeks then four-weekly as required to 44 weeks. | Drug | Ranibizumab |
| Modified ETDRS laserAlso: Argon laser photocoagulationArgon laser therapy to the macula in accordance with the modified ETDRS protocol at baseline, 12, 24 and 36 weeks. | Procedure or surgery | Laser |
Primary outcome
Functional and anatomical change in the retina
Time frame: 48 weeks
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.
2 secondary outcomes
Mean ETDRS acuity
Time frame: 48 weeks
OCT macular thickness
Time frame: 48 weeks
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 9 Sep 2020.
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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.
Philip G Hykin, FRCS FRCOphth principal investigator
Moorfields Eye Hospital NHS Trust
1 site 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 and Modified ETDRS laser in people with Diabetic Retinopathy, run by Moorfields Eye Hospital NHS Foundation Trust at 1 site 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 10 inclusion and 25 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 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Functional and anatomical change in the retina (time frame: 48 weeks). 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 9 Sep 2020.