- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02032173
Efficacy and Safety of Lucentis® Use in Patients With Diabetic Macular Edema Evaluating a Spaced Out Follow-up After Intensive Treatment Phase (CONSTELLATION)
A 24 Month Open-label, Multicenter, Phase IIIb Study of the Efficacy and Safety of Lucentis® (Ranibizumab 0,5mg) in Diabetic Patients With Visual Impairment Due to Macular Edema Evaluating a Spaced Out Follow-up After Intensive Loading Phase
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This was a multicenteric, open-label, phase IIIb study, which comprised of 2 groups: the Main Group and the Rescue Group.
Patient's eligibility was assessed during a screening visit (Visit 1) which took place 14 days maximum before treatment initiation (Visit 2 [Day 0]). All patients were initially included in the Main Group and were to receive an initial loading treatment (6 injections during the intensive treatment phase i.e. every month from Day 0 to Month 5, followed by 2 additional injections at Months 8 and 11). Patients were to be followed-up every 3 months for 18 months (spaced-out follow-up period). Their visual acuity was to be checked at each study visit (Months 3, 6, 8, 11, 14, 17, 20, and 23) to assess their response to treatment. Patients who responded to treatment were maintained in the Main Group. Patients who did not meet pre defined criteria were moved to the Rescue Group and treated at the investigator's discretion.
The trial was terminated before any patient reached month 12.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
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Bordeaux, France, 33000
- Novartis Investigative Site
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Bordeaux Cedex, France, F-33076
- Novartis Investigative Site
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Creteil, France, 94000
- Novartis Investigative Site
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Le Kremlin Bicetre Cedex, France, 94275
- Novartis Investigative Site
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Lyon, France, 69002
- Novartis Investigative Site
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Nice, France, 06000
- Novartis Investigative Site
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Paris, France, 75015
- Novartis Investigative Site
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Paris Cedex 19, France, 75940
- Novartis Investigative Site
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Poitiers, France, 86021
- Novartis Investigative Site
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Seine Saint Denis
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Bobigny cedex, Seine Saint Denis, France, 93009
- Novartis Investigative Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Type I or type II diabetes with HbA1c≤10%
- Visual impairment due to a diabetic macular edema
- Stable antidiabetic treatment (since more than 3 months) or hygiene-dietary
Exclusion Criteria:
- Inflammation or infection in one eye
- Women of childbearing potential without an efficient contraception, pregnant or breastfeeding
Other protocol-defined inclusion/exclusion criteria may apply
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ranibizumab 0.5mg
Intravitreal injection with standard dose of 0.5 mg/0.05mL
Pro re nata (PRN)
|
Intravitreal injection with standard dose of 0.5 mg/0.05mL
Pro re nata (PRN)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With a Stable BCVA in the Study Eye at 24 Months Compared With BCVA at 6 Months
Time Frame: Month 6 and 24
|
Best-Corrected Visual Acuity (BCVA) letters were measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters.
The range of EDTRS is 0 to 100 letters.
A positive change from baseline of BCVA indicates improvement.
Best value on the scale 100, worst 0. The number of participants with a stable BCVA (BCVA score at 6 months minus BCVA score at 24 months ≤4 letters) were reported.
|
Month 6 and 24
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With a Stable BCVA in the Study Eye at 24 Months Compared With BCVA at 11 Months
Time Frame: Month 11 and 24
|
Best-Corrected Visual Acuity (BCVA) letters were measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters.
The range of EDTRS is 0 to 100 letters.
A positive change from baseline of BCVA indicates improvement.
Best value on the scale 100, worst 0. The number of participants with a stable BCVA (BCVA score at 11 months minus BCVA score at 24 months ≤4 letters) was calculated as well as its confidence interval at 95%.
|
Month 11 and 24
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Visual Acuity: Number of Participants Keeping a BCVA Score Gain ≥10 Letters
Time Frame: Baseline, Month 3, 6, 8 and 11
|
Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters.
The range of EDTRS is 0 to 100 letters.
A positive change from baseline of BCVA indicates improvement.
Best value on the scale 100, worst 0. The number of participants maintaining ≥10 letters gains in BCVA (compared to the baseline BCVA [Day 0]) value for each visit from Month 3 onwards were reported.
|
Baseline, Month 3, 6, 8 and 11
|
Visual Acuity: Number of Participants Keeping a BCVA Score Gain ≥15 Letters
Time Frame: Baseline, Months 3, 6, 8 and 11
|
Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters.
The range of EDTRS is 0 to 100 letters.
A positive change from baseline of BCVA indicates improvement.
Best value on the scale 100, worst 0. The number of participants maintaining ≥15 letters gains in BCVA (compared to the baseline BCVA [Day 0]) value for each visit from Month 3 onwards were reported.
|
Baseline, Months 3, 6, 8 and 11
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Visual Acuity: Number of Participants With a BCVA Loss ≥15 Letters at Months 8 and 11 Compared to Month 6 in the Study Eye.
Time Frame: Months 6, 8 and 11
|
Best-Corrected Visual Acuity (BCVA) letters were measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters.
The range of EDTRS is 0 to 100 letters.
A positive change from baseline of BCVA indicates improvement.
Best value on the scale 100, worst 0. Number of participants presenting with a ≥15 letter loss in BCVA (compared to the value observed at 6 months) and leading to a treatment change (Rescue Group) for month 8 and 11 were analyzed.
|
Months 6, 8 and 11
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Visual Acuity : Change of BCVA From Baseline in the Study Eye (ETDRS)
Time Frame: Baseline, months 1, 2, 3, 4, 5, 6, 8 and 11
|
Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters.
The range of EDTRS is 0 to 100 letters.
A positive change from baseline of BCVA indicates improvement.
Best value on the scale 100, worst 0. The mean variation in BCVA was compared to the baseline BCVA value [Day 0] over a period of 24 months for patients in the Main Group.
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Baseline, months 1, 2, 3, 4, 5, 6, 8 and 11
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Central Retinal Thickness : Change of Log OCT From Baseline in the Study Eye
Time Frame: Baseline, months 1, 2, 3, 4, 5, 6, 8 and 11
|
Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye.
The retina is the light-sensitive part of the eye.
OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina.
A negative mean change from baseline indicates an improvement and a positive mean change from baseline indicates a worsening.The absolute variations of the Central Retinal Thickness (CRT) was measured using a Spectral Domain-Optical Coherence Tomography (SD-OCT) at each visit.
Values were calculated as a log OCT (=log[CRT/200]).
|
Baseline, months 1, 2, 3, 4, 5, 6, 8 and 11
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Visual Acuity : Change of BCVA From Baseline in the Study Eye (ETDRS) - Rescue Group
Time Frame: Baseline, Months 3, 6, 8 and 11
|
Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters.
The range of EDTRS is 0 to 100 letters.
A positive change from baseline of BCVA indicates improvement.
Best value on the scale 100, worst 0. The mean variation in BCVA was compared to the baseline BCVA value [Day 0] over a period of 24 months for patients in the Rescue Group.
|
Baseline, Months 3, 6, 8 and 11
|
Central Retinal Thickness : Change of Log OCT From Baseline in the Study Eye - Rescue Group
Time Frame: Baseline, Months 3, 6, 8 and 11
|
Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye.
The retina is the light-sensitive part of the eye.
OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina.
A negative mean change from baseline indicates an improvement and a positive mean change from baseline indicates a worsening.The absolute variations of the Central Retinal Thickness (CRT) measured using a Spectral Domain-Optical Coherence Tomography (SD-OCT) at each visit.
Values were calculated as a log OCT (=log[CRT/200]).
|
Baseline, Months 3, 6, 8 and 11
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Evaluation of the Spaced Out Follow-up on Visual Functions and Quality of Life
Time Frame: baseline, months 11, 12 and 24
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The global score obtained on the Visual Function Questionnaire 25 (VFQ 25) was compared from baseline to months 11 and 24 for the Main group and from baseline to months 12 and 24 for the Rescue group.
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baseline, months 11, 12 and 24
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRFB002DFR11
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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