Diabetic Macular EdemaPhase 3RETAINNCT01171976
Efficacy and Safety of Ranibizumab in Two "Treat and Extend" Treatment Algorithms Versus Ranibizumab As Needed in Patients With Macular Edema and Visual Impairment Secondary to Diabetes Mellitus
A Phase 3 study testing Ranibizumab in people with Diabetic Macular Edema, run by Novartis Pharmaceuticals at 68 sites in 13 countries.
Trial summary
The purpose of this study is to demonstrate that two investigational treatment regimens have the potential to result in a superior visual acuity improvement as compared to a ranibizumab pro re nata (PRN=as needed) treatment regimen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema
- 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
- 373 participants
- Where
- 68 sitesin 13 countries
- Study dates
- Sep 2010to Apr 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patient
- Patients with Type 1 or Type 2 diabetes mellitus (according to American Diabetes Association or World Health Organization [WHO] guidelines) with glycosylated hemoglobin (HbA1c) ≤ 12.0% at screening (Visit 1). Patients should be on diet, exercise, and/or pharmacological treatment for diabetes. Treatment for diabetes must have been stable for at least 3 month.
- Ocular
- Patients with visual impairment due to DME in at least one eye who are eligible for laser treatment in the opinion of the investigator. If both eyes are eligible, the one with the worse visual acuity, as assessed at Visit 1, will be selected by the investigator as the study eye.
- BCVA ≥ 39 and ≤78 letters in the study eye and, inclusively, using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters (approximate Snellen equivalent of 20/32 to 20/160) at screening.
- Concomitant conditions in the study eye are only permitted if, in the opinion of the investigator, they do not prevent improvement of visual acuity on study treatment.
Who cannot join
- Patient Compliance/ Administrative
- Pregnant or nursing (lactating) women.
- Ocular medical history
- Active intraocular inflammation (grade trace or above) in either eye at enrollment.
- Any active infection (e.g. conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) in either eye at the time of enrollment.
- History of uveitis in either eye at any time.
Show all 18Show fewer
- Structural damage within 0.5 disc diameter of the center of the macular in the study eye likely to preclude improvement in visual acuity following the resolution of macular edema.
- Uncontrolled glaucoma in either eye at screening.
- Prior Ocular treatments
- Panretinal laser photocoagulation in the study eye within 6 months prior to randomization.
- Focal/grid laser photocoagulation in the study eye within 3 months prior to randomization.
- Treatment with anti-angiogenic drugs in either eye.
- Systemic conditions or treatments
- History of stroke within 6 months prior to enrollment.
- Renal failure requiring dialysis.
- Untreated diabetes mellitus.
- Blood pressure systolic > 160 mmHg or diastolic > 100 mmHg.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
68 sites in 13 countries.
68 sites in 13 countries
United Kingdom10 sites
Novartis Investigative Site
Aberdeen, AB25 2ZN
Novartis Investigative Site
Bristol, BS1 2LX
Novartis Investigative Site
Frimley, Surrey, GU16 7UJ
Novartis Investigative Site
Leeds, LS9 7TF
Novartis Investigative Site
Manchester, M13 9WL
Novartis Investigative Site
Newcastle upon Tyne, NE1 4LP
Novartis Investigative Site
Sheffield, S10 2JF
Novartis Investigative Site
Southampton, SO16 6YD
Novartis Investigative Site
Sunderland, SR2 9HP
Novartis Investigative Site
Wolverhampton, WV10 0QP
France9 sites
Novartis Investigative Site
Bordeaux, 33 000
Novartis Investigative Site
Dijon, 21034
Novartis Investigative Site
Lille, 59 037
Novartis Investigative Site
Limoges, 87042
Novartis Investigative Site
Lyon, 69003
Novartis Investigative Site
Nantes, 44093
Novartis Investigative Site
Nice, 6 000
Novartis Investigative Site
Paris, 75015
Novartis Investigative Site
Paris, 75475
Spain8 sites
Novartis Investigative Site
Alicante, Valencia, 03016
Novartis Investigative Site
L'Hospitalet de Llobregat, Catalonia, 08907
Novartis Investigative Site
Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, 35016
Novartis Investigative Site
Madrid, Madrid, 28040
Novartis Investigative Site
Málaga, Andalusia, 29010
Novartis Investigative Site
Santiago de Compostela, Galicia, 15705
Novartis Investigative Site
Valencia, Valencia, 46015
Novartis Investigative Site
Valladolid, Castille and León, 47011
Italy6 sites
Novartis Investigative Site
Florence, FI, 50134
Novartis Investigative Site
Milan, MI, 20122
Novartis Investigative Site
Milan, MI, 20132
Novartis Investigative Site
Milan, MI, 20157
Novartis Investigative Site
Roma, RM, 00133
Novartis Investigative Site
Roma, RM, 00198
Czechia5 sites
Novartis Investigative Site
Hradec Králové, 505 05
Novartis Investigative Site
Olomouc, 775 20
Novartis Investigative Site
Pilsen, 301 00
Novartis Investigative Site
Prague, Czech Republic, 169 02
Novartis Investigative Site
Prague, 128 08
Netherlands5 sites
Novartis Investigative Site
Amsterdam, 1081 HV
Novartis Investigative Site
Amsterdam, 1105 AZ
Novartis Investigative Site
Leiden 2333 ZA, Netherlands, 2333
Novartis Investigative Site
Nijmegen, 6525 EX
Novartis Investigative Site
Rotterdam, 3011 BH
Hungary4 sites
Novartis Investigative Site
Budapest, 1083
Novartis Investigative Site
Budapest, 1133
Novartis Investigative Site
Debrecen, 4012
Novartis Investigative Site
Győr, 9024
Ireland4 sites
Novartis Investigative Site
Dublin, Ireland
Novartis Investigative Site
Dublin
Novartis Investigative Site
Kilkenny
Novartis Investigative Site
Limerick
Poland4 sites
Novartis Investigative Site
Bielsko-Biala, 43-300
Novartis Investigative Site
Lublin, 20-954
Novartis Investigative Site
Warsaw, 00-416
Novartis Investigative Site
Wroclaw, 50-367
Switzerland4 sites
Novartis Investigative Site
Bern, 3010
Novartis Investigative Site
Bern, 3012
Novartis Investigative Site
Binningen, 4102
Novartis Investigative Site
Zurich, Switzerland, 8063
Belgium3 sites
Novartis Investigative Site
Ghent, 9000
Novartis Investigative Site
Kortrijk, 8500
Novartis Investigative Site
Leuven, 3000
Greece3 sites
Novartis Investigative Site
Athens, 152 31
Novartis Investigative Site
Heraklion Crete, Crete, GR-71110
Novartis Investigative Site
Thessaloniki, 546 36
Portugal3 sites
Novartis Investigative Site
Coimbra, 3000-354
Novartis Investigative Site
Lisbon, 1150-199
Novartis Investigative Site
Porto, Portugal, 4099-001
About this study
Official title: A 2 Year Randomized, Single-masked, Multicenter, Controlled Phase IIIb Trial Assessing the Efficacy and Safety of 0.5 mg Ranibizumab in Two "Treat and Extend" Treatment Algorithms vs. 0.5 mg Ranibizumab As Needed in Patients With Macular Edema and Visual Impairment Secondary to Diabetes Mellitus
The purpose of this study is to demonstrate that two investigational treatment regimens have the potential to result in a superior visual acuity improvement as compared to a ranibizumab pro re nata (PRN=as needed) treatment regimen.
- Conditions
- Diabetic Macular Edema
- Being tested
- Ranibizumab
- Keywords
- DME, Diabetic macula edema, RETAIN, ranibizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanibizumabDrug
Ranibizumab (Lucentis®) was supplied in vials containing a dose of 0.5 mg/0.05 mL in an aqueous solution (pH 5.5) with histidine, trehalose, and polysorbate 20.
| Study group | Role | What they receive |
|---|---|---|
| TE Ranibizumab 0.5 mg and Laser | Experimental | On Day 1, all patients received an intravitreal injection with 0.5 mg ranibizumab and subsequently entered Phase A which comprised of monthly injections. Laser therapy was applied at Day 1. It could then be re-administered according to ETDRS criteria at any visit with 0.5 mg ranibizumab treatment if deemed necessary by the Treating Investigator with a minimal treatment interval between laser treatments of 3 months. Laser therapy was administered ≥ 30 minutes prior to the ranibizumab injection. Receives: Drug: Ranibizumab |
| TE Ranibizumab 0.5 mg alone | Experimental | Patients received ranibizumab intravitreal injection therapy only. Receives: Drug: Ranibizumab |
| PRN Ranibizumab 0.5 mg | Active comparator | Patients received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease. Receives: Drug: Ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity of the Study Eye: Average Change From Baseline to Month 1 Through Month 12
Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS-like VA testing charts at a starting distance of 4 meters.
Measured: Baseline to Month 12
Secondary outcomes (9)
Visual Acuity of the Study Eye: Average Change From Baseline to Month 1 Through Month 24
Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS-like VA testing charts at a starting distance of 4 meters.
Measured: Baseline to Month 24
Visual Acuity of the Study Eye: Change From Baseline at Month 12
Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS-like VA testing charts at a starting distance of 4 meters.
Measured: Baseline and Month 12
Visual Acuity of the Study Eye: Change From Baseline at Month 24
Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS-like VA testing charts at a starting distance of 4 meters.
Measured: Baseline and Month 24
Visual Acuity of the Study Eye: Categorized Change From Baseline at Month 12
Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS-like VA testing charts at a starting distance of 4 meters.
Measured: Baseline, Month 12
Visual Acuity of the Study Eye: Categorized Change From Baseline at Month 24
Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS-like VA testing charts at a starting distance of 4 meters.
Measured: Baseline, 24 month
Central Subfield Thickness of the Study Eye: Percent Change From Baseline at Month 12
High Resolution OCT was performed at every study visit by Spectral Domain OCT (if not available Time Domain OCT was acceptable) and the images were transferred to a digital video disc. These assessments were performed by trained and adequately qualified experts at the sites and prior to any study drug administration. CSFT is the average retinal thickness of the circular area with 1 mm diameter around the foveal center.
Measured: Baseline, Month 12
Central Subfield Thickness of the Study Eye: Percent Change From Baseline at Month 24
High Resolution OCT was performed at every study visit by Spectral Domain OCT (if not available Time Domain OCT was acceptable) and the images were transferred to a digital video disc. These assessments were performed by trained and adequately qualified experts at the sites and prior to any study drug administration. CSFT is the average retinal thickness of the circular area with 1 mm diameter around the foveal center.
Measured: Baseline and 24 month
Visual Functioning Questionnaire (VFQ-25) Change From Baseline in Total Score at Month 12 and Month 24
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) was used to measure the influence of visual disability and symptoms on general health. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. For each, the patient was asked to rate their condition on a scale of 1-5 or 1-6, where a low number reflects a better outcome. Each response was recoded per the scoring rules outlined in the National Eye Institute (NEI) VFQ-25 Scoring Algorithm. Under this scoring algorithm , the recoded values range between 0 and 100 and a high score means a better functioning
Measured: Baseline, Month 12 and Month 24
EuroQoL (EQ-5D) Thermometer Score: Change From Baseline at Month 12 and Month 24
The Euro Quality of Life Questionnaire (EQ-5D) is an indirect utility questionnaire. It is a standardized instrument was utilized to measure health outcomes related to 5 dimensions, namely: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The possible range for each dimension was 1 to 3, where 1= "no problems", 2="some problems" and 3="extreme problems" . A composite health index was then defined by combining the levels for each dimension. Overall, 243 health states are possible. For each health state, the EuroQol group has assigned a utility value typically between 0 and 1 with lower scores representing a higher level of dysfunction
Measured: Baseline, Month 12 and Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2010 (estimated)
- Study startSep 2010
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Macular EdemaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 373 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
- NCT01171976
- Sponsor's protocol ID
- CRFB002D2304
- Other IDs
- 2010-019795-74
- Acronym
- RETAIN
- Status last verified
- Sep 2014
- First submitted
- 27 Jul 2010
- Last updated
- 15 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Prunte C, Fajnkuchen F, Mahmood S, Ricci F, Hatz K, Studnicka J, Bezlyak V, Parikh S, Stubbings WJ, Wenzel A, Figueira J; RETAIN Study Group. Ranibizumab 0.5 mg treat-and-extend regimen for diabetic macular oedema: the RETAIN study. Br J Ophthalmol. 2016 Jun;100(6):787-95. doi: 10.1136/bjophthalmol-2015-307249. Epub 2015 Oct 9.
PubMed 26453639
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 2 Year Randomized, Single-masked, Multicenter, Controlled Phase IIIb Trial Assessing the Efficacy and Safety of 0.5 mg Ranibizumab in Two "Treat and Extend" Treatment Algorithms vs. 0.5 mg Ranibizumab As Needed in Patients With Macular Edema and Visual Impairment Secondary to Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01171976
- Acronym / sponsor ID
- RETAIN / CRFB002D2304
- Conditions
- Diabetic Macular Edema
- Keywords
- DME, Diabetic macula edema, RETAIN, ranibizumab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 373 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 29 Jul 2010 (estimated)
- Results
- Posted 15 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to demonstrate that two investigational treatment regimens have the potential to result in a superior visual acuity improvement as compared to a ranibizumab pro re nata (PRN=as needed) treatment regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TE Ranibizumab 0.5 mg and Laser | Experimental | Drug: RanibizumabOn Day 1, all patients received an intravitreal injection with 0.5 mg ranibizumab and subsequently entered Phase A which comprised of monthly injections. Laser therapy was applied at Day 1. It could then be re-administered according to ETDRS criteria at any visit with 0.5 mg ranibizumab treatment if deemed necessary by the Treating Investigator with a minimal treatment interval between laser treatments of 3 months. Laser therapy was administered ≥ 30 minutes prior to the ranibizumab injection. |
| TE Ranibizumab 0.5 mg alone | Experimental | Drug: RanibizumabPatients received ranibizumab intravitreal injection therapy only. |
| PRN Ranibizumab 0.5 mg | Active comparator | Drug: RanibizumabPatients received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient
- Patients with Type 1 or Type 2 diabetes mellitus (according to American Diabetes Association or World Health Organization [WHO] guidelines) with glycosylated hemoglobin (HbA1c) ≤ 12.0% at screening (Visit 1). Patients should be on diet, exercise, and/or pharmacological treatment for diabetes. Treatment for diabetes must have been stable for at least 3 month.
- Ocular
- Patients with visual impairment due to DME in at least one eye who are eligible for laser treatment in the opinion of the investigator. If both eyes are eligible, the one with the worse visual acuity, as assessed at Visit 1, will be selected by the investigator as the study eye.
- BCVA ≥ 39 and ≤78 letters in the study eye and, inclusively, using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters (approximate Snellen equivalent of 20/32 to 20/160) at screening.
Key exclusion criteria (18 listed)
- Patient Compliance/ Administrative
- Pregnant or nursing (lactating) women.
- Ocular medical history
- Active intraocular inflammation (grade trace or above) in either eye at enrollment.
- Any active infection (e.g. conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) in either eye at the time of enrollment.
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 |
|---|---|---|
| RanibizumabRanibizumab (Lucentis®) was supplied in vials containing a dose of 0.5 mg/0.05 mL in an aqueous solution (pH 5.5) with histidine, trehalose, and polysorbate 20. | Drug | PRN Ranibizumab 0.5 mg, TE Ranibizumab 0.5 mg alone, TE Ranibizumab 0.5 mg and Laser |
Primary outcome
Visual Acuity of the Study Eye: Average Change From Baseline to Month 1 Through Month 12
Time frame: Baseline to Month 12
Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS-like VA testing charts at a starting distance of 4 meters.
9 secondary outcomes
Visual Acuity of the Study Eye: Average Change From Baseline to Month 1 Through Month 24
Time frame: Baseline to Month 24
Visual Acuity of the Study Eye: Change From Baseline at Month 12
Time frame: Baseline and Month 12
Visual Acuity of the Study Eye: Change From Baseline at Month 24
Time frame: Baseline and Month 24
Visual Acuity of the Study Eye: Categorized Change From Baseline at Month 12
Time frame: Baseline, Month 12
Visual Acuity of the Study Eye: Categorized Change From Baseline at Month 24
Time frame: Baseline, 24 month
Central Subfield Thickness of the Study Eye: Percent Change From Baseline at Month 12
Time frame: Baseline, Month 12
Central Subfield Thickness of the Study Eye: Percent Change From Baseline at Month 24
Time frame: Baseline and 24 month
Visual Functioning Questionnaire (VFQ-25) Change From Baseline in Total Score at Month 12 and Month 24
Time frame: Baseline, Month 12 and Month 24
EuroQoL (EQ-5D) Thermometer Score: Change From Baseline at Month 12 and Month 24
Time frame: Baseline, Month 12 and Month 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26453639Prunte C, Fajnkuchen F, Mahmood S, Ricci F, Hatz K, Studnicka J, Bezlyak V, Parikh S, Stubbings WJ, Wenzel A, Figueira J; RETAIN Study Group. Ranibizumab 0.5 mg treat-and-extend regimen for diabetic macular oedema: the RETAIN study. Br J Ophthalmol. 2016 Jun;100(6):787-95. doi: 10.1136/bjophthalmol-2015-307249. Epub 2015 Oct 9.
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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
68 sites in 13 countries: 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 Edema, run by Novartis Pharmaceuticals at 68 sites in 13 countries.
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 6 inclusion and 18 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 15 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 68 sites in United Kingdom, France, Spain, Italy, Czechia and 8 more countries. 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?
Yes. Results are posted in the registry (first posted 15 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Visual Acuity of the Study Eye: Average Change From Baseline to Month 1 Through Month 12 (time frame: Baseline to Month 12). 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 NCT01171976, 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 15 Sep 2014.