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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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.

Country

City, postcode or hospital

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

Other trials in Germany

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

Other trials in Italy

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

Other trials in Hungary

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

Other trials in South Korea

Australia3 sites

Novartis Investigative Site
Adelaide, South Australia, 5000
Novartis Investigative Site
South Launceston, Tasmania, 7249
Novartis Investigative Site
Sydney, New South Wales, 2000

Other trials in Australia

Greece3 sites

Novartis Investigative Site
Heraklion Crete, GR, 711 10
Novartis Investigative Site
Pátrai, Greece, 265 00
Novartis Investigative Site
Thessaloniki, Greece, GR 56429

Other trials in Greece

Russia3 sites

Novartis Investigative Site
Kazan', 420012
Novartis Investigative Site
Moscow, 119021
Novartis Investigative Site
Moscow, 127486

Other trials in Russia

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

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Switzerland3 sites

Novartis Investigative Site
Bern, 3010
Novartis Investigative Site
Binningen, 4102
Novartis Investigative Site
Lausanne, 1007

Other trials in Switzerland

Turkey (Türkiye)3 sites

Novartis Investigative Site
Ankara, 06100
Novartis Investigative Site
Istanbul, 34420
Novartis Investigative Site
Kocaeli, 41380

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Czechia2 sites

Novartis Investigative Site
Hradec Králové, 505 05
Novartis Investigative Site
Prague, 100 34

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France2 sites

Novartis Investigative Site
Paris, France, F-75571
Novartis Investigative Site
Paris, 75010

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Lithuania2 sites

Novartis Investigative Site
Kaunas, LTU, 50009
Novartis Investigative Site
Vilnius, LT-08661

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Poland2 sites

Novartis Investigative Site
Katowice, 40-594
Novartis Investigative Site
Wroclaw, 50-556

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Portugal2 sites

Novartis Investigative Site
Coimbra, Portugal, 3000-354
Novartis Investigative Site
Porto, Portugal, 4200-319

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Slovakia2 sites

Novartis Investigative Site
Banská Bystrica, Slovakia, 97517
Novartis Investigative Site
Trenčín, Slovakia, 91171

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Canada1 site

Novartis Investigative Site
Montreal, Quebec, H1T 2M4

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Denmark1 site

Novartis Investigative Site
Glostrup Municipality, 2600

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Latvia1 site

Novartis Investigative Site
Riga, 1002

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Peru1 site

Novartis Investigative Site
San Isidro, Lima region, 27

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Singapore1 site

Novartis Investigative Site
Singapore, 168751

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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 groups in NCT01840410
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.

Sep 2013Nov 2015

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Choroidal Neovascularization (CNV) trials

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

Results posted to the registry on 26 Aug 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ranibizumab	119	112
Sham Control	59	55

Primary outcome: Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye to Month 2

Time frame: Baseline, Month 2. Least squares mean (Standard Error). Unit: letters

Measure	Ranibizumab n = 118	Sham Control n = 57
Value	9.5 (0.95)	-0.4 (1.16)

Ranibizumab vs Sham Control: Mean Difference (Net): 9.94 (95% CI 6.97 to 12.91), p <0.001, Mixed Models Analysis

Population analysed: The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at both baseline and Month 2, were analyzed.

13 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ranibizumab	9 of 119 (7.6%)	42 of 119 (35.3%)	Not reported
Sham With Ranibizumab	4 of 52 (7.7%)	19 of 52 (36.5%)	Not reported
Sham Without Ranibizumab	0 of 7 (0%)	4 of 7 (57.1%)	Not reported

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.

Related trials for Choroidal Neovascularization (CNV)

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)
Active, not recruitingPhase 2
Safety and Efficacy of ADVM-022 in Treatment-Experienced Patients With Neovascular Age-related Macular Degeneration [LUNA]
Neovascular Age-related Macular Degeneration
RecruitingPhase 2/3
A Clinical Trial of EYE201/MK-8748 in People With Macular Degeneration (MK-8748-002)
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Active, not recruiting
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Neovascular Age-Related Macular Degeneration (nAMD), Diabetic Macular Edema
Active, not recruitingPhase 1/2
NG101 AAV Gene Therapy in Subjects With Wet Age-Related Macular Degeneration
Age-Related Macular Degeneration

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?

On the ClinicalTrials.gov record for NCT01840410.

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.