Central Retinal Vein OcclusionPhase 3CamelliaNCT01976312
Ranibizumab Intravitreal Injections Versus Sham Control in Patients With Central Retinal Vein Occlusion (CRVO)
A Phase 3 study testing Ranibizumab 0.5 mg in people with Central Retinal Vein Occlusion, run by Novartis Pharmaceuticals at 34 sites in 7 countries.
Trial summary
Provide efficacy and safety data on intravitreal injections of ranibizumab 0.5 mg in patients with visual impairment due to macular edema secondary to CRVO Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Retinal Vein Occlusion
- What is being tested?
- Ranibizumab 0.5 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 252 participants
- Where
- 34 sitesin 7 countries
- Study dates
- 12 Nov 2013to 14 Mar 2016
- 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
- Patients with visual impairment secondary to central retinal vein occlusion (CRVO) with a BCVA between 24 and 73 letters in one eye and at least 35 letters in the other eye.
Who cannot join
- Pregnant or nursing women or women of child bearing potential unless using an effective contraception
- Stroke or myocard infarction within 3 months prior to study
- History of malignancy within the past 5 years
- Uncontrolled hypertension
- Active infection or inflammation in any eye
- use of corticosteroids for at least 30 days in the last 6 months
- treatment with anti-angiogenic drugs in any eye within last 3 months
- Panretinal or focal/drid laser photocoagulation within the last 3 and 4 months respectively
Trial locations and contacts
34 sites in 7 countries.
34 sites in 7 countries
China23 sites
Novartis Investigative Site
Beijing, Beijing Municipality, 100191
Novartis Investigative Site
Beijing, Beijing Municipality, 100730
Novartis Investigative Site
Beijing, 100034
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, Chongqing Municipality, 400042
Novartis Investigative Site
Chongqing, 400038
Novartis Investigative Site
Guangzhou, Guangdong, 510060
Novartis Investigative Site
Harbin, Heilongjiang, 150001
Novartis Investigative Site
Nanchang, Jiangxi, 330006
Novartis Investigative Site
Nanjing, Jiangsu, 210006
Novartis Investigative Site
Nanjing, Jiangsu, 210029
Novartis Investigative Site
Nantong, Jiangsu, 226000
Novartis Investigative Site
Qingdao, Shandong, 266011
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, 430070
India2 sites
Novartis Investigative Site
Ahmedabad, Gujarat, 380 016
Novartis Investigative Site
Bhubaneswar, Odisha, 751 024
Indonesia2 sites
Novartis Investigative Site
Bandung, West Java, 40117
Novartis Investigative Site
Jakarta, 10430
Philippines2 sites
Novartis Investigative Site
Manila, National Capital Region, 1000
Novartis Investigative Site
San Juan City, Philippines, 1500
Taiwan2 sites
Novartis Investigative Site
Linkou District, 33305
Novartis Investigative Site
Taipei
Vietnam2 sites
Novartis Investigative Site
Hanoi, 10000
Novartis Investigative Site
Ho Chi Minh City, 70000
About this study
Official title: A Randomized Double-masked, Phase III Study Assessing Ranibizumab Intravitreal Injections Versus Sham Control in Patients With Visual Impairment Due to Macular Edema (ME) Secondary to Central Retinal Vein Occlusion (CRVO) [Camellia]
Provide efficacy and safety data on intravitreal injections of ranibizumab 0.5 mg in patients with visual impairment due to macular edema secondary to CRVO
- Conditions
- Central Retinal Vein Occlusion
- Being tested
- Sham injection, Ranibizumab 0.5 mg
- Keywords
- CRVO, macular edema, vision impairment, retinal vein occlusion, ranibizumab
- Medical subject headings
- Retinal Vein Occlusion, Macular Edema, Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham injectionOther
Sham injections referred to the imitation of an intravitreal injection using an injection syringe without needle.
Ranibizumab 0.5 mgDrug
Also called Lucentis
Ranibizumab solution for injection was supplied in vials. Each vial contained ranibizumab concentration of 10mg/mL labeled as 0.5 mg/0.5 mL, corresponding to a 0.5 mg dose level. Ranibizumab was formulated as a sterile solution aseptically filled in a sterile glass vial for single use only
| Study group | Role | What they receive |
|---|---|---|
| Ranibizumab 0.5 mg | Experimental | PRN intravitreal injection Receives: Drug: Ranibizumab 0.5 mg |
| Sham injection | Sham comparator | As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections Receives: Other: Sham injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Change in Visual Acuity (Letters) From Baseline to Month 1 Through Month 3
Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters.
Mean Visual Acuity was averaged over all monthly assessments from month 1 to month 3 and compared to Baseline.
Measured: Baseline, 3 Months
Secondary outcomes (6)
Average Change of Best Corrected Visual Acuity (BCVA) From Baseline to Month 1 Through Month 12
Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. Mean Visual Acuity was averaged over all monthly assessments from month 1 to month 12 and compared to Baseline
Measured: Baseline, 12 months
Best Corrected Visual Acuity (BCVA) Change From Baseline 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: Month 1 to 12 months
Change From Baseline in Central-Sub-Field- Thickness (CSFT) Over Time
OCT (optical coherence tomography) 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.
Measured: Month 1 to month 12
Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time
Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters.
Measured: Month 1 to month 12
Number of Participants With Best Corrected Visual Acuity (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: Month 1 to 12 months
The Change in Patient Reported Outcomes in NEI-VFQ-25 Score (Composite Score and Subscales) at Month 3, 6 and 12 Compared to Baseline
The VFQ-25 consists of 25 vision related questions across 11 vision related subscales, including general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision and peripheral vision, and a general health rating. Items are converted to a 0-100 scale on each subscale and for the composite score where higher scores represents better functioning.
Measured: Month 3,6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2013 (estimated)
- Study start12 Nov 2013
- Primary completion14 Mar 2016
- Study completion14 Mar 2016
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 Central Retinal Vein OcclusionStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 252 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
- NCT01976312
- Sponsor's protocol ID
- CRFB002E2302
- Acronym
- Camellia
- Status last verified
- Apr 2017
- First submitted
- 18 Oct 2013
- Last updated
- 30 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-masked, Phase III Study Assessing Ranibizumab Intravitreal Injections Versus Sham Control in Patients With Visual Impairment Due to Macular Edema (ME) Secondary to Central Retinal Vein Occlusion (CRVO) [Camellia]
- ClinicalTrials.gov ID
- NCT01976312
- Acronym / sponsor ID
- Camellia / CRFB002E2302
- Conditions
- Central Retinal Vein Occlusion
- Keywords
- CRVO, macular edema, vision impairment, retinal vein occlusion, ranibizumab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 12 Nov 2013 (actual)
- Primary completion
- 14 Mar 2016 (actual)
- Study completion
- 14 Mar 2016 (actual)
- First posted
- 5 Nov 2013 (estimated)
- Results
- Posted 24 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Provide efficacy and safety data on intravitreal injections of ranibizumab 0.5 mg in patients with visual impairment due to macular edema secondary to CRVO
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ranibizumab 0.5 mg | Experimental | Drug: Ranibizumab 0.5 mgPRN intravitreal injection |
| Sham injection | Sham comparator | Other: Sham injectionAs of Month 3, ranibizumab 0.5 mg PRN intravitreal injections |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with visual impairment secondary to central retinal vein occlusion (CRVO) with a BCVA between 24 and 73 letters in one eye and at least 35 letters in the other eye.
Key exclusion criteria (8 listed)
- Pregnant or nursing women or women of child bearing potential unless using an effective contraception
- History of malignancy within the past 5 years
- Uncontrolled hypertension
- Active infection or inflammation in any eye
- use of corticosteroids for at least 30 days in the last 6 months
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 |
|---|---|---|
| Sham injectionSham injections referred to the imitation of an intravitreal injection using an injection syringe without needle. | Other | Sham injection |
| Ranibizumab 0.5 mgAlso: LucentisRanibizumab solution for injection was supplied in vials. Each vial contained ranibizumab concentration of 10mg/mL labeled as 0.5 mg/0.5 mL, corresponding to a 0.5 mg dose level. Ranibizumab was formulated as a sterile solution aseptically filled in a sterile glass vial for single use only | Drug | Ranibizumab 0.5 mg |
Primary outcome
Average Change in Visual Acuity (Letters) From Baseline to Month 1 Through Month 3
Time frame: Baseline, 3 Months
Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. Mean Visual Acuity was averaged over all monthly assessments from month 1 to month 3 and compared to Baseline.
6 secondary outcomes
Average Change of Best Corrected Visual Acuity (BCVA) From Baseline to Month 1 Through Month 12
Time frame: Baseline, 12 months
Best Corrected Visual Acuity (BCVA) Change From Baseline Over Time
Time frame: Month 1 to 12 months
Change From Baseline in Central-Sub-Field- Thickness (CSFT) Over Time
Time frame: Month 1 to month 12
Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time
Time frame: Month 1 to month 12
Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of <15 Letters in the Study Eye Over Time
Time frame: Month 1 to 12 months
The Change in Patient Reported Outcomes in NEI-VFQ-25 Score (Composite Score and Subscales) at Month 3, 6 and 12 Compared to Baseline
Time frame: Month 3,6 and 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
34 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ranibizumab 0.5 mg in people with Central Retinal Vein Occlusion, run by Novartis Pharmaceuticals at 34 sites in 7 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 1 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 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in China, India, Indonesia, Philippines, Taiwan and 2 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. Some participants in this study may receive a placebo. 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 24 Apr 2017). 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 Baseline to Month 1 Through Month 3 (time frame: Baseline, 3 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 30 May 2017.