Macular Edema (ME)Phase 3NCT01846299
To Assess the Efficacy and Safety of Intravitreal Ranibizumab in People With Vision Loss Due to Macular Edema
A Phase 3 study testing Ranibizumab in people with Macular Edema (ME), run by Novartis Pharmaceuticals at 61 sites in 19 countries.
Trial summary
To evaluate the efficacy and safety of 0.5 mg Ranibizumab intravitreal injections in adult patients with visual impairment due to macular edema (ME). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Macular Edema (ME)
- 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
- 181 participants
- Where
- 61 sitesin 19 countries
- Study dates
- Oct 2013to Sep 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 ME secondary to any causes (for adult patients: except diabetic macular edema (DME), age-related macular degeneration (AMD) and retinal vein occlusion (RVO));
- BCVA must be between ≥ 24 and ≤ 83 letters;
- Visual loss should be mainly due to the presence of any eligible types of ME.
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, related directly to the underlying causal disease of ME;
- Active diabetic retinopathy, active ocular/periocular infectious disease or active severe intra-ocular inflammation;
- Any type of advanced, severe or unstable ocular disease or its reatment;
- ME with a high likelihood of spontaneous resolution.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
61 sites in 19 countries.
61 sites in 19 countries
United Kingdom7 sites
Novartis Investigative Site
Birmingham, B18 7QU
Novartis Investigative Site
Bristol, BS1 2LX
Novartis Investigative Site
Frimley, Surrey, GU16 7UJ
Novartis Investigative Site
London, United Kingdom, EC1V 2PD
Novartis Investigative Site
Manchester, M13 9WL
Novartis Investigative Site
Southampton, SO16 6YD
Novartis Investigative Site
Sunderland, SR2 9HP
Italy6 sites
Novartis Investigative Site
Florence, FI, 50134
Novartis Investigative Site
Genova, GE, 16132
Novartis Investigative Site
Milan, MI, 20123
Novartis Investigative Site
Pisa, PI, 56124
Novartis Investigative Site
Roma, RM, 00133
Novartis Investigative Site
Torino, TO, 10122
Australia5 sites
Novartis Investigative Site
Adelaide, South Australia, 5000
Novartis Investigative Site
Hobart, Tasmania, 7000
Novartis Investigative Site
South Launceston, Tasmania, 7249
Novartis Investigative Site
Sydney, New South Wales, 2000
Novartis Investigative Site
Westmead, New South Wales, 2145
Israel5 sites
Novartis Investigative Site
Jerusalem, 9112001
Novartis Investigative Site
Kfar Saba, 4428164
Novartis Investigative Site
Petah Tikva, 49100
Novartis Investigative Site
Rehovot, 7610001
Novartis Investigative Site
Tel Aviv, 6423906
France4 sites
Novartis Investigative Site
Bordeaux, France, F-33076
Novartis Investigative Site
Lyon, 69003
Novartis Investigative Site
Paris, 75010
Novartis Investigative Site
Saint-Jean, 31240
Germany4 sites
Novartis Investigative Site
Düsseldorf, 40225
Novartis Investigative Site
Freiburg I. Br, 79106
Novartis Investigative Site
Leipzig, Germany, 04103
Novartis Investigative Site
Regensburg, Germany, 93042
Hungary4 sites
Novartis Investigative Site
Budapest, 1083
Novartis Investigative Site
Budapest, 1133
Novartis Investigative Site
Debrecen, 4012
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, 137-701
Novartis Investigative Site
Seoul, Seoul, 150-034
Spain4 sites
Novartis Investigative Site
L'Hospitalet de Llobregat, Barcelona, 08907
Novartis Investigative Site
Málaga, Andalusia, 29010
Novartis Investigative Site
Sant Cugat del Vallès, Catalonia, 08190
Novartis Investigative Site
Valladolid, Castille and León, 47011
Russia3 sites
Novartis Investigative Site
Kazan', 420012
Novartis Investigative Site
Moscow, 119021
Novartis Investigative Site
Moscow, 127486
Switzerland3 sites
Novartis Investigative Site
Bern, 3010
Novartis Investigative Site
Binningen, 4102
Novartis Investigative Site
Zurich, Switzerland, 8063
Czechia2 sites
Novartis Investigative Site
Pilsen, 301 00
Novartis Investigative Site
Prague, 100 34
Netherlands2 sites
Novartis Investigative Site
Amsterdam, 1105 AZ
Novartis Investigative Site
Tilburg, Netherlands, NL-5022GC
Slovakia2 sites
Novartis Investigative Site
Banská Bystrica, Slovakia, 97517
Novartis Investigative Site
Trenčín, Slovakia, 91171
Turkey (Türkiye)2 sites
Novartis Investigative Site
Ankara, 06100
Novartis Investigative Site
Kocaeli, 41380
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 Intravtitreal Injections in Patients With Visual Impairment Due to Vascular Endothelial Growth Factor (VEGF)Driven Macular Edema
To evaluate the efficacy and safety of 0.5 mg Ranibizumab intravitreal injections in adult patients with visual impairment due to macular edema (ME).
- Conditions
- Macular Edema (ME)
- Being tested
- Sham control, Ranibizumab
- Keywords
- Vision Impairment
- Medical subject headings
- Macular Edema, Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
RanibizumabDrug
Ranibizumab 0.5mg/0.5mL was administered intravitreally to the participant.
| 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 switched 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
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. 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. 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 wasassessed 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: Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Number of Participants With Presence or Absence of Intra-retinal Fluid in Study Eye Compared to Baseline
The presence of intra-retinal fluid was assessed by OCT.
Measured: Month 2, Month 6, Month 12
Number of Participants With Presence or Absence of Subretinal Fluid in Study Eye Compared to Baseline
The presence of subretinal fluid was assessed by OCT.
Measured: Month 2, Month 6, Month 12
Number of Participants With Presence of Active Macular Edema (ME) Leakage
The presence of active ME leakage was assessed by fluorescein angiography (FA).
Measured: Month 2
Number of Participants Requiring 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
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. 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 Ranibizumab Treatments
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 6, 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: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startOct 2013
- Primary completionSep 2015
- Study completionSep 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 Macular Edema (ME)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
- 181 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
- NCT01846299
- Sponsor's protocol ID
- CRFB002G2302
- Other IDs
- 2012-005418-20
- Status last verified
- Apr 2016
- First submitted
- 30 Apr 2013
- Last updated
- 23 May 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 23 May 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 Intravtitreal Injections in Patients With Visual Impairment Due to Vascular Endothelial Growth Factor (VEGF)Driven Macular Edema
- ClinicalTrials.gov ID
- NCT01846299
- Acronym / sponsor ID
- CRFB002G2302
- Conditions
- Macular Edema (ME)
- Keywords
- Vision Impairment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 3 May 2013 (estimated)
- Results
- Posted 23 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy and safety of 0.5 mg Ranibizumab intravitreal injections in adult patients with visual impairment due to macular edema (ME).
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 switched 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 ME secondary to any causes (for adult patients: except diabetic macular edema (DME), age-related macular degeneration (AMD) and retinal vein occlusion (RVO));
- BCVA must be between ≥ 24 and ≤ 83 letters;
- Visual loss should be mainly due to the presence of any eligible types of ME.
Key exclusion criteria (8 listed)
- Women of child-bearing potential,
- Active malignancies;
- History of stroke less than 6 months prior to screening;
- Uncontrolled systemic inflammation or infection, related directly to the underlying causal disease of ME;
- 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 |
|---|---|---|
| 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 |
| RanibizumabRanibizumab 0.5mg/0.5mL was administered intravitreally to the participant. | Drug | Ranibizumab |
Primary outcome
Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye
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. 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: Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Number of Participants With Presence or Absence of Intra-retinal Fluid in Study Eye Compared to Baseline
Time frame: Month 2, Month 6, Month 12
Number of Participants With Presence or Absence of Subretinal Fluid in Study Eye Compared to Baseline
Time frame: Month 2, Month 6, Month 12
Number of Participants With Presence of Active Macular Edema (ME) Leakage
Time frame: Month 2
Number of Participants Requiring Rescue Treatment at Month 1
Time frame: Month 1
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 Ranibizumab Treatments
Time frame: Month 12
Number of Participants With Re-treatments
Time frame: Month 6, month 12
Number of Primary Reasons for Decision to Treat by Investigator
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 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
61 sites in 19 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 Macular Edema (ME), run by Novartis Pharmaceuticals at 61 sites in 19 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 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 23 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 sites in United Kingdom, Italy, Australia, Israel, France and 14 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 23 May 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 (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 23 May 2016.