Diabetic Macular EdemaPhase 3REFINENCT02259088
A 12-month, Randomized, Efficacy and Safety Study of 0.5 mg Ranibizumab vs Laser in Chinese Diabetic Macular Edema (DME) Patients
A Phase 3 study testing Ranibizumab (RFB002) and Laser in people with Diabetic Macular Edema and Visual Impairment, run by Novartis Pharmaceuticals at 28 sites in China.
Trial summary
Study of efficacy and safety of 0.5 mg ranibizumab in Chinese patients with diabetic macular edema (DME) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema, Visual Impairment
- What is being tested?
- Ranibizumab (RFB002) and Laser
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 384 participants
- Where
- 28 sitesChina
- Study dates
- 5 Nov 2014to 17 Jan 2017
- 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
- Male or female Chinese patients ≥ 18 years of age with diabetes mellitus and with HbA1c ≤10.0%
- Stable medication for diabetes within 3 months prior to Visit 1
- Visual impairment due to DME with BCVA score between 78 and 39 letters as measured by ETDRS-like charts at 4 meters
Who cannot join
- Stroke or myocardial infarction less than 3 months prior to screening visit
- Uncontrolled hypertension
- Active ocular infection or intraocular inflammation in any eye
- Treatment with any anti-angiogenic drugs within 3 months prior to baseline visit in any eye
- Active proliferative diabetic retinopathy in study eye
- Use of other investigational drugs within 30 days and systemic anti-VEGF drugs within 6 months prior to baseline visit
- Prior laser photocoagulation or intraocular procedure within 3 months prior to baseline in study eye
- History of intravitreal corticosteroid treatment in phakic study eye, and in aphakic or pseudophakic within 3 months prior to screening
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
China28 sites
Novartis Investigative Site
Beijing, Beijing Municipality, 100044
Novartis Investigative Site
Beijing, Beijing Municipality, 100191
Novartis Investigative Site
Beijing, Beijing Municipality, 100730
Novartis Investigative Site
Beijing, 100034
Novartis Investigative Site
Beijing, 100050
Novartis Investigative Site
Beijing, 100053
Novartis Investigative Site
Beijing, 100176
Novartis Investigative Site
Beijing, 100730
Novartis Investigative Site
Changsha, Hunan, 410011
Novartis Investigative Site
Chengdu, Sichuan, 610041
Novartis Investigative Site
Chongqing, 400042
Novartis Investigative Site
Guangzhou, Guangdong, 510060
Novartis Investigative Site
Guangzhou, Guangdong, 510632
Novartis Investigative Site
Hangzhou, Zhejiang, 310003
Novartis Investigative Site
Hangzhou, Zhejiang, 310014
Novartis Investigative Site
Harbin, Heilongjiang, 150001
Novartis Investigative Site
Nanchang, Jiangxi, 330019
Novartis Investigative Site
Qingdao, Shandong, 2666000
Novartis Investigative Site
Shanghai, 200080
Novartis Investigative Site
Shanghai, 200092
Novartis Investigative Site
Shantou, Guangdong, 515041
Novartis Investigative Site
Tianjin, Tianjin Municipality, 300020
Novartis Investigative Site
Tianjin, Tianjin Municipality, 300070
Novartis Investigative Site
Wenzhou, Zhejiang, 325027
Novartis Investigative Site
Wuhan, Hubei, 430022
Novartis Investigative Site
Wuhan, Hubei, 430070
Novartis Investigative Site
Wuxi, Jiangsu
Novartis Investigative Site
Xi’an, Shanxi, 710032
About this study
Official title: A 12-month, Randomized, Double-masked, Multicenter, Laser-controlled Phase III Study Assessing the Efficacy and Safety of 0.5 mg Ranibizumab Dosed PRN in Subjects With Visual Impairment Due to Diabetic Macular Edema in Chinese Patients
Study of efficacy and safety of 0.5 mg ranibizumab in Chinese patients with diabetic macular edema (DME)
Read the detailed description
The purpose of this study was to provide efficacy and safety data on 0.5 mg ranibizumab intravitreal injections compared to laser photocoagulation in Chinese patients with visual impairment due to DME. Treatment was driven by achieving vision stabilization.
- Conditions
- Diabetic Macular Edema, Visual Impairment
- Being tested
- Ranibizumab (RFB002), Laser, Sham injection, Sham laser
- Keywords
- DME, macular edema, vision impairment, Chinese, diabetes
- Medical subject headings
- Vision Disorders, Macular Edema, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ranibizumab (RFB002)Drug
Also called Lucentis
Ranibizumab 0.5 mg/0.05 mL for intravitreal injection
LaserProcedure or surgery
Laser photocoagulation according to Early Treatment Diabetic Retinopathy Study (ETDRS) guidelines
Sham injectionDrug
Imitation of an intravitreal injection consisting of an empty vial and an injection syringe without a needle
Sham laserProcedure or surgery
Imitation of an active laser
| Study group | Role | What they receive |
|---|---|---|
| Ranibizumab (RFB002) | Experimental | 3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser Receives: Drug: Ranibizumab (RFB002); Procedure: Sham laser |
| Laser | Active comparator | Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections Receives: Procedure: Laser; Drug: Sham injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Average Change From Baseline in Best-Corrected Visual Acuity (BCVA) (Letters) to Month 1 Through 12
Visual acuity with eyeglasses was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at an initial testing distance of 4 meters. A letter score was calculated based on the number of letters correctly identified at the specified distance. Twelve monthly BCVA values were averaged [(Month1+Month2+...+Month12)/12], and the baseline BCVA value was subtracted from the average. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. One eye (study eye) contributed to the analysis.
Measured: Baseline, Monthly from Month 1 through Month 12
Secondary outcomes (20)
Mean Change From Baseline in BCVA (Letters) at Each Visit
Visual acuity with eyeglasses was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at an initial testing distance of 4 meters. A letter score was calculated based on the number of letters correctly identified at the specified distance. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. One eye (study eye) contributed to the analysis.
Measured: Baseline, Monthly from Month 1 through Month 12
Mean Change From Baseline in Central Sub-Field Thickness (CSFT) at Each Visit
CSFT (the average retinal thickness of the circular area within 1 millimeter diameter around the foveal center) was assessed using Optical Coherence Tomography (OCT). A negative change value indicates an improvement in macular edema, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis.
Measured: Baseline, Monthly from Month 1 through Month 12
Percentage of Patients With BCVA Gain of ≥ 10 and ≥ 15 Letters From Baseline at Month 12
Visual acuity with eyeglasses was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at an initial testing distance of 4 meters. A letter score was calculated based on the number of letters correctly identified at the specified distance. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. One eye (study eye) contributed to the analysis.
Measured: Baseline, Month 12
Percentage of Patients With BCVA Loss of < 10 and < 15 Letters From Baseline to Month 12
Visual acuity with eyeglasses was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at an initial testing distance of 4 meters. A letter score was calculated based on the number of letters correctly identified at the specified distance. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. One eye (study eye) contributed to the analysis.
Measured: Baseline, Month 12
Percentage of Patients With BCVA ≥ 73 Letters at Month 12
Visual acuity with eyeglasses was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at an initial testing distance of 4 meters. A letter score was calculated based on the number of letters correctly identified at the specified distance. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. BCVA ≥ 73 letters is approximately equivalent to 20/40 on a Snellen chart. One eye (study eye) contributed to the analysis.
Measured: Month 12
Mean Average Change in BCVA From Month 4 to Month 12 Compared to Month 3
Visual acuity with eyeglasses was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at an initial testing distance of 4 meters. A letter score was calculated based on the number of letters correctly identified at the specified distance. Nine monthly BCVA values were averaged [(Month4+Month5+...+Month12)/9],and the Month 3 BCVA value was subtracted from the average. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. One eye (study eye) contributed to the analysis.
Measured: Monthly from Month 3 through Month 12
Mean Change From Baseline in Patient-Reported Visual Functioning at Month 6 and Month 12, Composite Score
Visual functioning was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in visual functioning, while a negative change value indicates a worsening.
Measured: Baseline, Month 6, Month 12
Mean Change From Baseline in Patient-Reported General Health at Month 6 and Month 12
General health was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in general health, while a negative change value indicates a worsening.
Measured: Baseline, Month 6, Month 12
Mean Change From Baseline in Patient-Reported General Vision at Month 6 and Month 12
General vision was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in general vision, while a negative change value indicates a worsening.
Measured: Baseline, Month 6, Month 12
Mean Change From Baseline in Patient-Reported Color Vision at Month 6 and Month 12
Color vision was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in color vision, while a negative change value indicates a worsening.
Measured: Baseline, Month 6, Month 12
Mean Change From Baseline in Patient-Reported Peripheral Vision at Month 6 and Month 12
Peripheral vision was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in peripheral vision, while a negative change value indicates a worsening.
Measured: Baseline, Month 6, Month 12
Mean Change From Baseline in Patient-Reported Ocular Pain at Month 6 and Month 12
Ocular pain was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in ocular pain, while a negative change value indicates a worsening.
Measured: Baseline, Month 6, Month 12
Mean Change From Baseline in Patient-Reported Near Activities at Month 6 and Month 12
Near activities were assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in near activities, while a negative change value indicates a worsening.
Measured: Baseline, Month 6, Month 12
Mean Change From Baseline in Patient-Reported Distance Activities at Month 6 and Month 12
Distance activities were assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in distance activities, while a negative change value indicates a worsening.
Measured: Baseline, Month 6, Month 12
Mean Change From Baseline in Patient-Reported Social Functioning at Month 6 and Month 12
Social functioning was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in social functioning, while a negative change value indicates a worsening.
Measured: Baseline, Month 6, Month 12
Mean Change From Baseline in Patient-Reported Mental Health at Month 6 and Month 12
Mental health was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in mental health, while a negative change value indicates a worsening.
Measured: Baseline, Month 6, Month 12
Mean Change From Baseline in Patient-Reported Roles Difficulties at Month 6 and Month 12
Roles difficulties were assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in roles difficulties, while a negative change value indicates a worsening.
Measured: Baseline, Month 6, Month 12
Mean Change From Baseline in Patient-Reported Dependency at Month 6 and Month 12
Dependency was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in dependency, while a negative change value indicates a worsening.
Measured: Baseline, Month 6, Month 12
Mean Change From Baseline in Patient-Reported Driving at Month 6 and Month 12
Driving was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in driving, while a negative change value indicates a worsening. Note: Many patients did not answer the driving related question as they did not drive at all.
Measured: Baseline, Month 6, Month 12
Mean Number of Ranibizumab Re-treatments Received in the Study Eye From Month 3 Onward
A ranibizumab re-treatment was defined as an administration of ranibizumab injection at a scheduled visit following at least one non-missed visit where ranibizumab was not administered in the study eye due to visual acuity stabilization. This outcome measure was pre-specified for the Ranibizumab 0.5 mg arm only.
Measured: Monthly from Month 3 through Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2014 (estimated)
- Study start5 Nov 2014
- Primary completion17 Jan 2017
- Study completion17 Jan 2017
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.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 384 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
- NCT02259088
- Sponsor's protocol ID
- CRFB002D2305
- Acronym
- REFINE
- Status last verified
- Jan 2019
- First submitted
- 3 Oct 2014
- Last updated
- 1 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-month, Randomized, Double-masked, Multicenter, Laser-controlled Phase III Study Assessing the Efficacy and Safety of 0.5 mg Ranibizumab Dosed PRN in Subjects With Visual Impairment Due to Diabetic Macular Edema in Chinese Patients
- ClinicalTrials.gov ID
- NCT02259088
- Acronym / sponsor ID
- REFINE / CRFB002D2305
- Conditions
- Diabetic Macular Edema, Visual Impairment
- Keywords
- DME, macular edema, vision impairment, Chinese, diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 384 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 5 Nov 2014 (actual)
- Primary completion
- 17 Jan 2017 (actual)
- Study completion
- 17 Jan 2017 (actual)
- First posted
- 8 Oct 2014 (estimated)
- Results
- Posted 1 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study of efficacy and safety of 0.5 mg ranibizumab in Chinese patients with diabetic macular edema (DME)
Detailed description
The purpose of this study was to provide efficacy and safety data on 0.5 mg ranibizumab intravitreal injections compared to laser photocoagulation in Chinese patients with visual impairment due to DME. Treatment was driven by achieving vision stabilization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ranibizumab (RFB002) | Experimental | Drug: Ranibizumab (RFB002), Procedure: Sham laser3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser |
| Laser | Active comparator | Procedure: Laser, Drug: Sham injectionLaser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female Chinese patients ≥ 18 years of age with diabetes mellitus and with HbA1c ≤10.0%
- Stable medication for diabetes within 3 months prior to Visit 1
- Visual impairment due to DME with BCVA score between 78 and 39 letters as measured by ETDRS-like charts at 4 meters
Key exclusion criteria (8 listed)
- Stroke or myocardial infarction less than 3 months prior to screening visit
- Uncontrolled hypertension
- Active ocular infection or intraocular inflammation in any eye
- Treatment with any anti-angiogenic drugs within 3 months prior to baseline visit in any eye
- Active proliferative diabetic retinopathy in study eye
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 |
|---|---|---|
| Ranibizumab (RFB002)Also: LucentisRanibizumab 0.5 mg/0.05 mL for intravitreal injection | Drug | Ranibizumab (RFB002) |
| LaserLaser photocoagulation according to Early Treatment Diabetic Retinopathy Study (ETDRS) guidelines | Procedure or surgery | Laser |
| Sham injectionImitation of an intravitreal injection consisting of an empty vial and an injection syringe without a needle | Drug | Laser |
| Sham laserImitation of an active laser | Procedure or surgery | Ranibizumab (RFB002) |
Primary outcome
Mean Average Change From Baseline in Best-Corrected Visual Acuity (BCVA) (Letters) to Month 1 Through 12
Time frame: Baseline, Monthly from Month 1 through Month 12
Visual acuity with eyeglasses was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at an initial testing distance of 4 meters. A letter score was calculated based on the number of letters correctly identified at the specified distance. Twelve monthly BCVA values were averaged [(Month1+Month2+...+Month12)/12], and the baseline BCVA value was subtracted from the average. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. One eye (study eye) contributed to the analysis.
20 secondary outcomes
Mean Change From Baseline in BCVA (Letters) at Each Visit
Time frame: Baseline, Monthly from Month 1 through Month 12
Mean Change From Baseline in Central Sub-Field Thickness (CSFT) at Each Visit
Time frame: Baseline, Monthly from Month 1 through Month 12
Percentage of Patients With BCVA Gain of ≥ 10 and ≥ 15 Letters From Baseline at Month 12
Time frame: Baseline, Month 12
Percentage of Patients With BCVA Loss of < 10 and < 15 Letters From Baseline to Month 12
Time frame: Baseline, Month 12
Percentage of Patients With BCVA ≥ 73 Letters at Month 12
Time frame: Month 12
Mean Average Change in BCVA From Month 4 to Month 12 Compared to Month 3
Time frame: Monthly from Month 3 through Month 12
Mean Change From Baseline in Patient-Reported Visual Functioning at Month 6 and Month 12, Composite Score
Time frame: Baseline, Month 6, Month 12
Mean Change From Baseline in Patient-Reported General Health at Month 6 and Month 12
Time frame: Baseline, Month 6, Month 12
Mean Change From Baseline in Patient-Reported General Vision at Month 6 and Month 12
Time frame: Baseline, Month 6, Month 12
Mean Change From Baseline in Patient-Reported Color Vision at Month 6 and Month 12
Time frame: Baseline, Month 6, Month 12
Mean Change From Baseline in Patient-Reported Peripheral Vision at Month 6 and Month 12
Time frame: Baseline, Month 6, Month 12
Mean Change From Baseline in Patient-Reported Ocular Pain at Month 6 and Month 12
Time frame: Baseline, Month 6, Month 12
Mean Change From Baseline in Patient-Reported Near Activities at Month 6 and Month 12
Time frame: Baseline, Month 6, Month 12
Mean Change From Baseline in Patient-Reported Distance Activities at Month 6 and Month 12
Time frame: Baseline, Month 6, Month 12
Mean Change From Baseline in Patient-Reported Social Functioning at Month 6 and Month 12
Time frame: Baseline, Month 6, Month 12
Mean Change From Baseline in Patient-Reported Mental Health at Month 6 and Month 12
Time frame: Baseline, Month 6, Month 12
Mean Change From Baseline in Patient-Reported Roles Difficulties at Month 6 and Month 12
Time frame: Baseline, Month 6, Month 12
Mean Change From Baseline in Patient-Reported Dependency at Month 6 and Month 12
Time frame: Baseline, Month 6, Month 12
Mean Change From Baseline in Patient-Reported Driving at Month 6 and Month 12
Time frame: Baseline, Month 6, Month 12
Mean Number of Ranibizumab Re-treatments Received in the Study Eye From Month 3 Onward
Time frame: Monthly from Month 3 through Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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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
28 sites 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 (RFB002) and Laser in people with Diabetic Macular Edema and Visual Impairment, run by Novartis Pharmaceuticals at 28 sites in China.
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 3 inclusion and 8 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 1 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in China. 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 1 Feb 2019). 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?
Mean Average Change From Baseline in Best-Corrected Visual Acuity (BCVA) (Letters) to Month 1 Through 12 (time frame: Baseline, Monthly from Month 1 through Month 12). 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 1 Feb 2019.