Choroidal Neovascularization (CNV)Phase 3NCT01840410
Assess the Efficacy/Safety of Intravitreal Ranibizumab in Patients With Vision Loss Due to Choroidal Neovascularization.
A Phase 3 study testing Ranibizumab in people with Choroidal Neovascularization (CNV), run by Novartis Pharmaceuticals at 59 sites in 21 countries.
Trial summary
This study was conducted to evaluate the efficacy and safety of 0.5 mg ranibizumab in adult and adolescent patients with visual impairment due to choridal neovascularization (CNV). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Choroidal Neovascularization (CNV)
- What is being tested?
- Ranibizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 183 participants
- Where
- 59 sitesin 21 countries
- Study dates
- Sep 2013to Nov 2015
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of active CNV secondary to any causes with the CNV or its sequelae affecting the fovea;
- BCVA must be between ≥ 24 and ≤ 83 letters in the study eye;
- Visual loss in the study eye should mainly be due to the presence of any eligible types of CNV;
Who cannot join
- Women of child-bearing potential;
- Active malignancies;
- History of stroke less than 6 months prior to screening;
- Uncontrolled systemic inflammation or infection;
- Active diabetic retinopathy, active ocular/periocular infectious disease or active severe intra-ocular inflammation;
- CNV- conditions with a high likelihood of spontaneous resolution;
Show all 9Show fewer
- History of intravitreal treatment with steroids;
- History of laser photocoagulation;
- History of intraocular treatment with any anti-angiogenic drugs.
Trial locations and contacts
59 sites in 21 countries.
59 sites in 21 countries
Germany9 sites
Novartis Investigative Site
Bochum, 44892
Novartis Investigative Site
Bonn, 53127
Novartis Investigative Site
Düsseldorf, 40225
Novartis Investigative Site
Freiburg I. Br, 79106
Novartis Investigative Site
Leipzig, Germany, 04103
Novartis Investigative Site
Münster, 48145
Novartis Investigative Site
Münster, 48149
Novartis Investigative Site
Regensburg, Germany, 93042
Novartis Investigative Site
Tübingen, 72076
Italy6 sites
Novartis Investigative Site
Bari, BA, 70124
Novartis Investigative Site
Catania, CT, 95123
Novartis Investigative Site
Milan, MI, 20132
Novartis Investigative Site
Roma, RM, 00198
Novartis Investigative Site
Udine, UD, 33100
Novartis Investigative Site
Varese, VA, 21100
Hungary5 sites
Novartis Investigative Site
Budapest, 1083
Novartis Investigative Site
Budapest, 1133
Novartis Investigative Site
Debrecen, 4012
Novartis Investigative Site
Debrecen, 4043
Novartis Investigative Site
Szeged, H-6720
South Korea4 sites
Novartis Investigative Site
Busan, Busan, 602-739
Novartis Investigative Site
Seoul, Korea, 03080
Novartis Investigative Site
Seoul, Korea, 06591
Novartis Investigative Site
Seoul, Seoul, 150-034
Australia3 sites
Novartis Investigative Site
Adelaide, South Australia, 5000
Novartis Investigative Site
South Launceston, Tasmania, 7249
Novartis Investigative Site
Sydney, New South Wales, 2000
Greece3 sites
Novartis Investigative Site
Heraklion Crete, GR, 711 10
Novartis Investigative Site
Pátrai, Greece, 265 00
Novartis Investigative Site
Thessaloniki, Greece, GR 56429
Russia3 sites
Novartis Investigative Site
Kazan', 420012
Novartis Investigative Site
Moscow, 119021
Novartis Investigative Site
Moscow, 127486
Spain3 sites
Novartis Investigative Site
Málaga, Andalusia, 29010
Novartis Investigative Site
Sant Cugat del Vallès, Catalonia, 08190
Novartis Investigative Site
Valladolid, Castille and León, 47011
Switzerland3 sites
Novartis Investigative Site
Bern, 3010
Novartis Investigative Site
Binningen, 4102
Novartis Investigative Site
Lausanne, 1007
Turkey (Türkiye)3 sites
Novartis Investigative Site
Ankara, 06100
Novartis Investigative Site
Istanbul, 34420
Novartis Investigative Site
Kocaeli, 41380
Czechia2 sites
Novartis Investigative Site
Hradec Králové, 505 05
Novartis Investigative Site
Prague, 100 34
France2 sites
Novartis Investigative Site
Paris, France, F-75571
Novartis Investigative Site
Paris, 75010
Lithuania2 sites
Novartis Investigative Site
Kaunas, LTU, 50009
Novartis Investigative Site
Vilnius, LT-08661
Poland2 sites
Novartis Investigative Site
Katowice, 40-594
Novartis Investigative Site
Wroclaw, 50-556
Portugal2 sites
Novartis Investigative Site
Coimbra, Portugal, 3000-354
Novartis Investigative Site
Porto, Portugal, 4200-319
Slovakia2 sites
Novartis Investigative Site
Banská Bystrica, Slovakia, 97517
Novartis Investigative Site
Trenčín, Slovakia, 91171
About this study
Official title: A 12-month, Randomized, Double-masked, Sham-controlled, Multicenter Study to Evaluate the Efficacy and Safety of 0.5mg Ranibizumab Intravitreal Injections in Patients With Visual Impairment Due to Vascular Endothelial Growth Factor (VEGF) Driven Choroidal Neovascularization.
This study was conducted to evaluate the efficacy and safety of 0.5 mg ranibizumab in adult and adolescent patients with visual impairment due to choridal neovascularization (CNV).
- Conditions
- Choroidal Neovascularization (CNV)
- Being tested
- Ranibizumab, Sham control
- Keywords
- Vision Impairment, Abnormal growth of blood vessels
- Medical subject headings
- Choroidal Neovascularization, Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanibizumabDrug
Ranibizumab 0.5mg/0.5mL was administered intravitreally to the participant.
Sham controlOther
The sham vial did not contain active drug (empty sterile vial). The sham injection was an imitation of an intravitreal injection using an injection syringe without a needle touching the eye.
| Study group | Role | What they receive |
|---|---|---|
| Ranibizumab | Experimental | A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity. Receives: Drug: Ranibizumab |
| Sham control | Sham comparator | Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis. Receives: Other: Sham control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye to Month 2
BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. The data were analyzed using mixed model repeated measures (MMRM) which contained scheduled visit, the type of underlying pathophysiologic mechanism (angloid streaks versus others) and treatment group as fixed effect factors, centered baseline BCVA as a continuous covariate and treatment group by visit and visit by centered baseline BCVA interactions. A positive change from baseline indicated improvement.
Measured: Baseline, Month 2
Secondary outcomes (13)
Change From Baseline in BCVA in Study Eye up to Month 2
BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. The data were analyzed using analysis of covariance (ANCOVA) model which contained the type of underlying pathophysiologic mechanism (angloid streaks versus others) and treatment group as fixed effect factors, centered baseline BCVA as a continuous covariate. A positive change from baseline indicated improvement.
Measured: Baseline, Month 1, Month 2
Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye
CSFT was assessed by optical coherence tomography (OCT). A negative change from baseline indicates improvement.
Measured: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Change From Baseline in Central Subfield Volume (CSFV) in Study Eye
CSFV was assessed OCT. A negative change from baseline indicates improvement.
Measured: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Number of Participants With Presence of Intra-retinal Fluid in Study Eye Compared to Baseline
The presence of intra-retinal fluid was assessed by OCT.
Measured: Baseline, Month 2, Month 6, Month 12
Number of Participants With Presence of Subretinal Fluid in Study Eye Compared to Baseline
Presence of subretinal fluid in study eye compared to baseline
Measured: Baseline, Month 2, Month 6, Month 12
Number of Participants With Presence of Active Chorioretinal Leakage
The presence of active chorioretinal leakage was assessed by photography imaging, i.e. fluorescein angiography (FA).
Measured: Baseline, Month 2, Month 6, Month 12
Average Change From Baseline in BCVA
BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. BCVA was assessed at each month from Month 1 through Month 6 or at each month from Month 1 through month 12, and the data were averaged. The outcome measure is reporting the change between baseline and average BCVA from Month 1 through Month 6 or from Month 1 through Month 12 (average BCVA - baseline BCVA). A positive change from baseline indicated improvement.
Measured: Baseline (BL), Month 1 through Month 6, Month 1 through Month 12
Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters
VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using ETDRS-like visual acuity testing charts at a testing distance of 4 meters.
Measured: Month 2, Month 6, Month 12
Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss
VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using ETDRS-like visual acuity testing charts at a testing distance of 4 meters.
Measured: Month 2, Month 6, Month 12
Number of Participants With Requirement for Rescue Treatment at Month 1
Rescue treatment with laser photocoagulation or periocular treatment could be administered at Month 1 only if the participant had a visual acuity loss of > 5 letters due to disease activity from baseline to Month 1.
Measured: Month 1
Number of Participants With Ranibizumab Treatments in Study Eye
The number of participants administered study treatments, according to treatment frequency, was assessed.
Measured: Month 12
Number of Participants With Re-treatments
The number of participants, administered re-treatments according to treatment frequency, was assessed. Re-treatment was defined as an administration of study medication following at least one non-missed visit where treatment was not administered in the study eye. Up to month 12, the maximum number of retreatments was 5.
Measured: Month 12
Number of Primary Reasons for Decision to Treat by Investigator
The total number of primary reasons for decisions to treat was assessed. A single participant could have had multiple primary reasons for treatment.
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2013 (estimated)
- Study startSep 2013
- Primary completionNov 2015
- Study completionNov 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 Choroidal Neovascularization (CNV)Studies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 183 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
- NCT01840410
- Sponsor's protocol ID
- CRFB002G2301
- Other IDs
- 2012-005417-38
- Status last verified
- Aug 2016
- First submitted
- 23 Apr 2013
- Last updated
- 26 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-month, Randomized, Double-masked, Sham-controlled, Multicenter Study to Evaluate the Efficacy and Safety of 0.5mg Ranibizumab Intravitreal Injections in Patients With Visual Impairment Due to Vascular Endothelial Growth Factor (VEGF) Driven Choroidal Neovascularization.
- ClinicalTrials.gov ID
- NCT01840410
- Acronym / sponsor ID
- CRFB002G2301
- Conditions
- Choroidal Neovascularization (CNV)
- Keywords
- Vision Impairment, Abnormal growth of blood vessels
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 25 Apr 2013 (estimated)
- Results
- Posted 26 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was conducted to evaluate the efficacy and safety of 0.5 mg ranibizumab in adult and adolescent patients with visual impairment due to choridal neovascularization (CNV).
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 | Experimental | Drug: RanibizumabA 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity. |
| Sham control | Sham comparator | Other: Sham controlSham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of active CNV secondary to any causes with the CNV or its sequelae affecting the fovea;
- BCVA must be between ≥ 24 and ≤ 83 letters in the study eye;
- Visual loss in the study eye should mainly be due to the presence of any eligible types of CNV;
Key exclusion criteria (9 listed)
- Women of child-bearing potential;
- Active malignancies;
- History of stroke less than 6 months prior to screening;
- Uncontrolled systemic inflammation or infection;
- Active diabetic retinopathy, active ocular/periocular infectious disease or active severe intra-ocular inflammation;
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 0.5mg/0.5mL was administered intravitreally to the participant. | Drug | Ranibizumab |
| Sham controlThe sham vial did not contain active drug (empty sterile vial). The sham injection was an imitation of an intravitreal injection using an injection syringe without a needle touching the eye. | Other | Sham control |
Primary outcome
Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye to Month 2
Time frame: Baseline, Month 2
BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. The data were analyzed using mixed model repeated measures (MMRM) which contained scheduled visit, the type of underlying pathophysiologic mechanism (angloid streaks versus others) and treatment group as fixed effect factors, centered baseline BCVA as a continuous covariate and treatment group by visit and visit by centered baseline BCVA interactions. A positive change from baseline indicated improvement.
13 secondary outcomes
Change From Baseline in BCVA in Study Eye up to Month 2
Time frame: Baseline, Month 1, Month 2
Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye
Time frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Change From Baseline in Central Subfield Volume (CSFV) in Study Eye
Time frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Number of Participants With Presence of Intra-retinal Fluid in Study Eye Compared to Baseline
Time frame: Baseline, Month 2, Month 6, Month 12
Number of Participants With Presence of Subretinal Fluid in Study Eye Compared to Baseline
Time frame: Baseline, Month 2, Month 6, Month 12
Number of Participants With Presence of Active Chorioretinal Leakage
Time frame: Baseline, Month 2, Month 6, Month 12
Average Change From Baseline in BCVA
Time frame: Baseline (BL), Month 1 through Month 6, Month 1 through Month 12
Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters
Time frame: Month 2, Month 6, Month 12
Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss
Time frame: Month 2, Month 6, Month 12
Number of Participants With Requirement for Rescue Treatment at Month 1
Time frame: Month 1
Number of Participants With Ranibizumab Treatments in Study Eye
Time frame: Month 12
Number of Participants With Re-treatments
Time frame: Month 12
Number of Primary Reasons for Decision to Treat by Investigator
Time frame: Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2016.
- 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
59 sites in 21 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 Choroidal Neovascularization (CNV), run by Novartis Pharmaceuticals at 59 sites in 21 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 3 inclusion and 9 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 26 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 sites in Germany, Italy, Hungary, South Korea, Australia and 16 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 26 Aug 2016). 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?
Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye to Month 2 (time frame: Baseline, Month 2). 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 26 Aug 2016; AzTrials last refreshed its copy on 8 Nov 2026.