Neovascular Age-related Macular DegenerationPhase 4DRAGONNCT01775124
Efficacy and Safety of Ranibizumab 0.5 mg Administered as Two Alternative Dosing Regimens in Chinese Patients With nAMD (Age Related Macular Degeneration)
A Phase 4 study testing Ranibizumab in people with Neovascular Age-related Macular Degeneration, run by Novartis Pharmaceuticals at 23 sites in China.
Trial summary
The study evaluated the efficacy and safety of two different dosing regimens of ranibizumab (either monthly injections or injections as-needed based on the stability of a patient's vision) in Chinese patients with wet age-related macular degeneration (AMD) . Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Neovascular Age-related Macular Degeneration
- 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
- 332 participants
- Where
- 23 sitesChina
- Study dates
- 22 Feb 2013to 23 Nov 2015
- Phase
- Phase 4
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with visual impairment due to neovascular AMD
- A qualifying vision score at study entry Key Exclusion criteria
- Active infection or inflammation either eye at study entry
- Uncontrolled glaucoma in either eye
- Any disorder in the study eye which may affect vision
- Use of any systemic anti-vascular endothelial growth factor (VEGF)-drugs within 3 months prior to study entry
- Previous treatment of the study eye for wet AMD
- Any surgery in the study eye 3 months prior to or planned with 6 month after study entry
Who cannot join
None listed.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
China23 sites
Novartis Investigative Site
Beijing, Beijing Municipality, 100191
Novartis Investigative Site
Beijing, Beijing Municipality, 100730
Novartis Investigative Site
Beijing, 100044
Novartis Investigative Site
Beijing, 100176
Novartis Investigative Site
Changsha, Hunan, 410011
Novartis Investigative Site
Chengdu, Sichuan, 610041
Novartis Investigative Site
Chongqing, Chongqing Municipality, 400042
Novartis Investigative Site
Chongqing, 400038
Novartis Investigative Site
Harbin, Heilongjiang, 150001
Novartis Investigative Site
Lanzhou, Gansu, 730030
Novartis Investigative Site
Nanchang, Jiangxi, 330006
Novartis Investigative Site
Nanjing, Jiangsu, 210029
Novartis Investigative Site
Qingdao, Shandong, 2666000
Novartis Investigative Site
Shanghai, 200031
Novartis Investigative Site
Shanghai, 200080
Novartis Investigative Site
Shanghai, 200092
Novartis Investigative Site
Shenyang, Liaoning, 110011
Novartis Investigative Site
Taiyuan, Shanxi, 030002
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, 430060
Novartis Investigative Site
Wuhan, Hubei, 430070
About this study
Official title: A 24-month, Randomized, Double-masked, Controlled, Multicenter Study Evaluating the Efficacy and Safety of Ranibizumab 0.5 mg Administered as Two Alternative Dosing Regimens in Chinese Patients With Neovascular Age Related Macular Degeneration (AMD)
The study evaluated the efficacy and safety of two different dosing regimens of ranibizumab (either monthly injections or injections as-needed based on the stability of a patient's vision) in Chinese patients with wet age-related macular degeneration (AMD) . This study was to provide long-term safety data in the treatment of Chinese patients with wet AMD.
- Being tested
- Ranibizumab
- Keywords
- Macular degeneration,, age-related macular degeneration (ARMD),, vision loss,, macula damage,, retina damage,, dry macular degeneration,, wet macular degeneration,, AMD
- Medical subject headings
- Macular Degeneration, Vision Disorders, Geographic Atrophy, Wet Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanibizumabDrug
Intravitreal injections of 0.5 mg Ranibizumab
| Study group | Role | What they receive |
|---|---|---|
| Ranibizumab 0.5 mg monthly | Experimental | Monthly intravitreal injections of ranibizumab 0.5 mg in the core treatment period and PRN intravitreal injections of the same dose guided by best-corrected visual acuity (BCVA) stabilization in the extension treatment period Receives: Drug: Ranibizumab |
| Ranibizumab 0.5 mg pro re nata (PRN) | Experimental | PRN intravitreal injections of ranibizumab 0.5 mg guided by best-corrected visual acuity (BCVA) stabilization in the 23 month treatment period Receives: Drug: Ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Change in Visual Acuity (Letters) From Month 3 to Month 4 Through Month 12
Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like VA testing charts at a testing distance of 4 meters. This outcome measure describes the difference between the VA averaged across all visits from Month 4 through 12 and the Month 3 Level of Visual Acuity (Letters) of the Study Eye. The treatment regimen up to Month 3 is the same in both treatment groups.
Measured: Month 3 to month 4 through Month 12
Secondary outcomes (11)
Average Visual Acuity Change (Letters) From Month 3 to Month 4 Through Month 24
Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes the difference between the average level of VA over all monthly post-baseline assessments from Month 4 to Month 24 and the Month 3 Level of VA. The treatment regimen up to Month 3 is the same in both treatment groups.
Measured: Month 3 to month 4 through Month 24
Average Visual Acuity Change From Baseline to Month 1 Through Month 12 and Month 1 Through Month 24
Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes the difference between VA averaged across all visits from Month 1 through Month 12 (24) and the baseline VA level
Measured: Baseline to Month 24
Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time
Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes the change in visual acuity at each visit compared to baseline
Measured: Baseline to 24 months
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Visual acuity (VA) was at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes for each post-baseline month whether or not a patient improved by equal or more than 5, 10, 15,or 30 letters of VA as compared to baseline.
Measured: Baseline to Month 24
Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time
Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes for each post-baseline month whether or not a patient lost less than 15 letters of VA as compared with baseline.
Measured: Baseline to Month 24
Number of Patients With a Best Corrected Visual Acuity (BCVA) of More of 73 Letters or More
Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes for Month 12 and Month 24 whether a patient had a VA score of 73 or more letters
Measured: Month 12 and 24
Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24
Optical coherence tomography(OCT) was used to assess CSFT (Central Sub-Field Thickness) representing the average retinal thickness of the circular area within 1 mm diameter around the foveal center. The Ns in the rows is the number of patients with a value for both baseline and the specific post-baseline visit
Measured: Baseline to Month 24
Duration of Ranibizumab Treatment Free Interval in the Study Eye up to Month 24
This outcome measure describes duration of treatment-free intervals. Treatment-free interval is defined as the number of visits (whether attended or not) where ranibizumab was not administered. n= the number of patients who had at least one ranibizumab treatment interruption
Measured: up to month 24
Duration of Ranibizumab Treatment Free Interval in the Study Eye Prior to Month 12
This outcome measure describes duration of treatment-free intervals prior to month 12. Treatment-free interval is defined as the number of visits (whether attended or not) where ranibizumab was not administered. n= the number of patients who had at least one ranibizumab treatment interruption Treatment-free interval is analyzed in the Ranibizumab 0.5 mg PRN group only. It is not analyzed in the Ranibizumab 0.5 mg monthly group because, by protocol design, these participants receive treatment monthly. Therefore, the analysis does not apply to this group.
Measured: prior to month 12
Duration of Active Treatment Phase Prior to Month 12
Measured: Prior to month 12
Duration of Active Treatment Phase up to Month 24
Measured: up to month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2013 (estimated)
- Study start22 Feb 2013
- Primary completion23 Nov 2015
- Study completion23 Nov 2015
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 Neovascular Age-related Macular DegenerationStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 332 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
- NCT01775124
- Sponsor's protocol ID
- CRFB002A2413
- Acronym
- DRAGON
- Status last verified
- Aug 2019
- First submitted
- 22 Jan 2013
- Last updated
- 4 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24-month, Randomized, Double-masked, Controlled, Multicenter Study Evaluating the Efficacy and Safety of Ranibizumab 0.5 mg Administered as Two Alternative Dosing Regimens in Chinese Patients With Neovascular Age Related Macular Degeneration (AMD)
- ClinicalTrials.gov ID
- NCT01775124
- Acronym / sponsor ID
- DRAGON / CRFB002A2413
- Keywords
- Macular degeneration,, age-related macular degeneration (ARMD),, vision loss,, macula damage,, retina damage,, dry macular degeneration,, wet macular degeneration,, AMD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 332 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 22 Feb 2013 (actual)
- Primary completion
- 23 Nov 2015 (actual)
- Study completion
- 23 Nov 2015 (actual)
- First posted
- 24 Jan 2013 (estimated)
- Results
- Posted 12 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study evaluated the efficacy and safety of two different dosing regimens of ranibizumab (either monthly injections or injections as-needed based on the stability of a patient's vision) in Chinese patients with wet age-related macular degeneration (AMD) . This study was to provide long-term safety data in the treatment of Chinese patients with wet AMD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ranibizumab 0.5 mg monthly | Experimental | Drug: RanibizumabMonthly intravitreal injections of ranibizumab 0.5 mg in the core treatment period and PRN intravitreal injections of the same dose guided by best-corrected visual acuity (BCVA) stabilization in the extension treatment period |
| Ranibizumab 0.5 mg pro re nata (PRN) | Experimental | Drug: RanibizumabPRN intravitreal injections of ranibizumab 0.5 mg guided by best-corrected visual acuity (BCVA) stabilization in the 23 month treatment period |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with visual impairment due to neovascular AMD
- A qualifying vision score at study entry Key Exclusion criteria
- Active infection or inflammation either eye at study entry
- Uncontrolled glaucoma in either eye
- Any disorder in the study eye which may affect vision
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| RanibizumabIntravitreal injections of 0.5 mg Ranibizumab | Drug | Ranibizumab 0.5 mg monthly, Ranibizumab 0.5 mg pro re nata (PRN) |
Primary outcome
Average Change in Visual Acuity (Letters) From Month 3 to Month 4 Through Month 12
Time frame: Month 3 to month 4 through Month 12
Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like VA testing charts at a testing distance of 4 meters. This outcome measure describes the difference between the VA averaged across all visits from Month 4 through 12 and the Month 3 Level of Visual Acuity (Letters) of the Study Eye. The treatment regimen up to Month 3 is the same in both treatment groups.
11 secondary outcomes
Average Visual Acuity Change (Letters) From Month 3 to Month 4 Through Month 24
Time frame: Month 3 to month 4 through Month 24
Average Visual Acuity Change From Baseline to Month 1 Through Month 12 and Month 1 Through Month 24
Time frame: Baseline to Month 24
Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time
Time frame: Baseline to 24 months
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Time frame: Baseline to Month 24
Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time
Time frame: Baseline to Month 24
Number of Patients With a Best Corrected Visual Acuity (BCVA) of More of 73 Letters or More
Time frame: Month 12 and 24
Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24
Time frame: Baseline to Month 24
Duration of Ranibizumab Treatment Free Interval in the Study Eye up to Month 24
Time frame: up to month 24
Duration of Ranibizumab Treatment Free Interval in the Study Eye Prior to Month 12
Time frame: prior to month 12
Duration of Active Treatment Phase Prior to Month 12
Time frame: Prior to month 12
Duration of Active Treatment Phase up to Month 24
Time frame: up to month 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Neovascular Age-related Macular Degeneration
RecruitingPhase 3
A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD
Neovascular Age-related Macular Degeneration
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 1/2
Phase 1/2 Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration
Age-Related Macular Degeneration, Geographic Atrophy
Active, not recruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer and Tabirafusp Tedromer Compared to Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD) - DAYBREAK
Wet Age-related Macular Degeneration
Not yet recruitingPhase 2
A Study to Evaluate the Efficacy and Safety of VIS-101 in Participants With Neovascular Age-Related Macular Degeneration
Neovascular Age Related Macular Degeneration(nAMD)
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
23 sites 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 in people with Neovascular Age-related Macular Degeneration, run by Novartis Pharmaceuticals at 23 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 8 inclusion and 0 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 4 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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 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?
Yes. Results are posted in the registry (first posted 12 Feb 2018). 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?
Average Change in Visual Acuity (Letters) From Month 3 to Month 4 Through Month 12 (time frame: Month 3 to month 4 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 4 Sep 2019.