Diabetic Macular OedemaPhase 3CONTROLNCT03495765
To Evaluate the Comparative Efficacy of Lucentis (Ranibizumab) 0.5mg Intravitreal Injection in Patients With Diabetic Macular Oedema (DME) With Well Controlled and Poorly Controlled Diabetes Mellitus
A Phase 3 study testing Ranibizumab in people with Diabetic Macular Oedema, run by Marsden Eye Specialists at 1 site in Australia.
Trial summary
To demonstrate the comparative effectiveness of 12 months of Lucentis (ranibizumab) in patients with well controlled compared to those with poorly controlled diabetes using an PRN treatment schedule. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Macular Oedema
- What is being tested?
- Ranibizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteAustralia
- Study dates
- Mar 2011to 1 Jan 2017
- Phase
- Phase 3
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female patients with diabetes > 21 years of age who have signed an informed consent
- Patients with either Type 1 or Type 2 diabetes mellitus (according to ADA or WHO guidelines) with HbA1c levels either < 7.5% or ≥ 10.0% at screening (visit 1) as measured within the last 3 months.
- Patients with visual impairment due to either focal or diffuse DME in at least one eye who are eligible for laser treatment in the opinion of the investigator. The study eye must fulfill the following criteria at Visit 1 (if both eyes are eligible, the study eye will be selected by the investigator, based on potential for improvement): i) BCVA score between 73 and 39 letters, inclusively, using LogMAR visual acuity testing charts at 4 metres (or at the equivalent appropriate testing distance for the chart size) (approximate Snellen equivalent between 6/12 (20/40) and 6/48 (20/160); ii) the decrease in vision is due to DME but not due to other causes, in the opinion of the investigator
- OCT foveal centre point thickness ≥ 350µm on Spectral Domain OCT (≥300 µm on Time domain OCT / STRATUS)
- Medication for the management of diabetes should have been stable within the 3 months prior to randomisation
Who cannot join
- Concomitant conditions in the study eye which could, in the opinion of the investigator, prevent the improvement of visual acuity on study treatment
- Active intraocular inflammation (grade trace or above) in either eye
- Any active infection (e.g. conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) in either eye
- History of uveitis in either eye
- Structural damage within 1 disc diameter of the center of the macula in the study eye likely to preclude an improvement in visual acuity following the resolution of macular oedema, including (geographic) atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s), or organized hard exudates plaques
- Ocular disorders in the study eye that may confound interpretation of study results, compromise visual acuity or require medical or surgical intervention during the 12-month study period, including retinal vascular occlusion, retinal detachment, epiretinal membrane, macular hole, or choroidal neovascularization of any cause (e.g., AMD, ocular histoplasmosis, or pathologic myopia)
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- Uncontrolled glaucoma in the study eye (according to investigator's judgment)
- Neovascularization of the iris in study eye
- Evidence of vitreomacular traction in study eye, shown either clinically or on OCT
- Panretinal laser photocoagulation in the study eye within 6 months (in order to exclude patients with active proliferative disease) or focal/grid laser photocoagulation in the study eye within 3 months prior to study entry
- Treatment with anti-angiogenic drugs: pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, aflibercept (VEGF-Trap) within 3 months to study eye
- Intravitreal corticosteroids in either eye within 6 months prior to randomisation
- Any intraocular surgery in the study eye within 3 months prior to randomisation
- History of vitrectomy in study eye
- Phakic study eye with a history of intravitreal corticosteroid treatment (due to the likely late increase in secondary cataract)
- Ocular conditions in the study eye that is likely to require chronic concomitant therapy with topical ocular or systemically administered corticosteroids
- History of disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, that might affect the interpretation of the results of the study, or that would renders the patient at high risk from treatment complications
- Renal failure requiring dialysis or renal transplant OR renal insufficiency with creatinine levels >2.0 mg/dl
- Untreated diabetes mellitus
- Severe (blood pressure systolic > 160 mmHg OR diastolic > 100 mmHg)
- Current use of or likely need for systemic medications known to be toxic to the lens, retina or optic nerve, including Deferoxamine, Chloroquine/ hydroxychloroquine (Plaquenil), Tamoxifen, Phenothiazines and Ethambutol
- Known hypersensitivity to ranibizumab or any component of the ranibizumab formulation
- Previous participation in any clinical studies of investigational drugs (excluding vitamins and minerals) within 1 month (or a period corresponding to 5 half-lives of the investigational drug, whatever is longer) prior to randomisation
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they are using two birth control methods. The two methods can be a double barrier method or a barrier method plus a hormonal method. Adequate barrier methods of contraception include: diaphragm, condom (by the partner), intrauterine device (copper or hormonal), sponge or spermicide. Hormonal contraceptives include any marketed contraceptive agent that includes an estrogen and/or a progestational agent.
- Pregnant or nursing (lactating) women.
- Inability to comply with study or follow-up procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Multi-centre, 12-month Study to Evaluate the Comparative Efficacy of Lucentis (Ranibizumab) 0.5mg Intravitreal Injection in Patients With Diabetic Macular Oedema (DME) With Well Controlled and Poorly Controlled Diabetes Mellitus ('CONTROL' Study)
To demonstrate the comparative effectiveness of 12 months of Lucentis (ranibizumab) in patients with well controlled compared to those with poorly controlled diabetes using an PRN treatment schedule.
Read the detailed description
To demonstrate the comparative effectiveness of Lucentis (ranibizumab) in patients with well controlled compared to those with poorly controlled diabetes.
The primary endpoint for the study will be the mean change in best-corrected visual acuity (BCVA) from baseline to Month 12.
Two groups of patients, based on HbA1c levels will be entered into the trial -
- patients with a recent HbA1c level < 7.5 % (the 'well controlled' subgroup) and
- patients with a recent HbA1c level ≥ 10.0% (the 'poorly controlled' subgroup).
Ranibizumab treatment will be administered over the 12-month period, initial 3 monthly injections, followed by 'as needed' protocol using the following principles:
Monthly ranibizumab injections would be suspended when:
- No further BCVA improvement from treatment at the last 2 consecutive follow up visits OR
- BCVA letter score >84 (6/6) at the last 2 consecutive follow up visits
Monthly ranibizumab injections would be reinitiated when:
- Decrease in BCVA due to DME progression in the opinion of the investigator Laser treatment could also be administered from 3 months after study initiation, according to the investigators decision, in accordance with ETDRS guidelines, and at intervals of at least 3 months from the last treatment.
Visit schedule: Screening visit then monthly visits for 12 visits (total of 13 visits)
- Conditions
- Diabetic Macular Oedema
- Being tested
- Ranibizumab
- Keywords
- Diabetic macular oedema, Lucentis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanibizumabDrug
Also called Lucentis
Ranibizumab 0.5mcg via intravitreal injection to study eye up to monthly
| Study group | Role | What they receive |
|---|---|---|
| Well controlled | Active comparator | Eligibile people with diabetic macular oedema and HBA1C < 7.5 Receives: Drug: Ranibizumab |
| Poorly controlled | Active comparator | eligible people with Diabetic macular oedema and HBAIC >10.0 Receives: Drug: Ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint for the study will be the mean change in best-corrected visual acuity (BCVA) from baseline to the mean level at Month 12.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study startMar 2011
- Primary completion1 Jan 2017
- Study completion1 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular OedemaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marsden Eye Specialists
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Jennifer Arnold, Marsden Eye Specialists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03495765
- Sponsor's protocol ID
- Control1
- Acronym
- CONTROL
- Status last verified
- Apr 2018
- First submitted
- 3 Apr 2018
- Last updated
- 12 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-centre, 12-month Study to Evaluate the Comparative Efficacy of Lucentis (Ranibizumab) 0.5mg Intravitreal Injection in Patients With Diabetic Macular Oedema (DME) With Well Controlled and Poorly Controlled Diabetes Mellitus ('CONTROL' Study)
- ClinicalTrials.gov ID
- NCT03495765
- Acronym / sponsor ID
- CONTROL / Control1
- Conditions
- Diabetic Macular Oedema
- Keywords
- Diabetic macular oedema, Lucentis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Marsden Eye SpecialistsUniversity, hospital or other
- Study start
- Mar 2011 (actual)
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 1 Jan 2017 (actual)
- First posted
- 12 Apr 2018 (actual)
- 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.
To demonstrate the comparative effectiveness of 12 months of Lucentis (ranibizumab) in patients with well controlled compared to those with poorly controlled diabetes using an PRN treatment schedule.
Detailed description
To demonstrate the comparative effectiveness of Lucentis (ranibizumab) in patients with well controlled compared to those with poorly controlled diabetes.
The primary endpoint for the study will be the mean change in best-corrected visual acuity (BCVA) from baseline to Month 12.
Two groups of patients, based on HbA1c levels will be entered into the trial -
- patients with a recent HbA1c level < 7.5 % (the 'well controlled' subgroup) and
- patients with a recent HbA1c level ≥ 10.0% (the 'poorly controlled' subgroup).
Ranibizumab treatment will be administered over the 12-month period, initial 3 monthly injections, followed by 'as needed' protocol using the following principles:
Monthly ranibizumab injections would be suspended when:
- No further BCVA improvement from treatment at the last 2 consecutive follow up visits OR
- BCVA letter score >84 (6/6) at the last 2 consecutive follow up visits
Monthly ranibizumab injections would be reinitiated when:
- Decrease in BCVA due to DME progression in the opinion of the investigator Laser treatment could also be administered from 3 months after study initiation, according to the investigators decision, in accordance with ETDRS guidelines, and at intervals of at least 3 months from the last treatment.
Visit schedule: Screening visit then monthly visits for 12 visits (total of 13 visits)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Well controlled | Active comparator | Drug: RanibizumabEligibile people with diabetic macular oedema and HBA1C < 7.5 |
| Poorly controlled | Active comparator | Drug: Ranibizumabeligible people with Diabetic macular oedema and HBAIC >10.0 |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female patients with diabetes > 21 years of age who have signed an informed consent
- Patients with either Type 1 or Type 2 diabetes mellitus (according to ADA or WHO guidelines) with HbA1c levels either < 7.5% or ≥ 10.0% at screening (visit 1) as measured within the last 3 months.
- Patients with visual impairment due to either focal or diffuse DME in at least one eye who are eligible for laser treatment in the opinion of the investigator. The study eye must fulfill the following criteria at Visit 1 (if both eyes are eligible, the study eye will be selected by the investigator, based on potential for improvement): i) BCVA score between 73 and 39 letters, inclusively, using LogMAR visual acuity testing charts at 4 metres (or at the equivalent appropriate testing distance for the chart size) (approximate Snellen equivalent between 6/12 (20/40) and 6/48 (20/160); ii) the decrease in vision is due to DME but not due to other causes, in the opinion of the investigator
- OCT foveal centre point thickness ≥ 350µm on Spectral Domain OCT (≥300 µm on Time domain OCT / STRATUS)
- Medication for the management of diabetes should have been stable within the 3 months prior to randomisation
Key exclusion criteria (26 listed)
- Concomitant conditions in the study eye which could, in the opinion of the investigator, prevent the improvement of visual acuity on study treatment
- Active intraocular inflammation (grade trace or above) in either eye
- Any active infection (e.g. conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) in either eye
- History of uveitis in either eye
- Structural damage within 1 disc diameter of the center of the macula in the study eye likely to preclude an improvement in visual acuity following the resolution of macular oedema, including (geographic) atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s), or organized hard exudates plaques
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: LucentisRanibizumab 0.5mcg via intravitreal injection to study eye up to monthly | Drug | Poorly controlled, Well controlled |
Primary outcome
The primary endpoint for the study will be the mean change in best-corrected visual acuity (BCVA) from baseline to the mean level at Month 12.
Time frame: 12 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 12 Apr 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ranibizumab in people with Diabetic Macular Oedema, run by Marsden Eye Specialists at 1 site in Australia.
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 26 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 12 Apr 2018. 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 Australia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 primary endpoint for the study will be the mean change in best-corrected visual acuity (BCVA) from baseline to the mean level at Month 12. (time frame: 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 12 Apr 2018.