Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety of Lucentis® Use in Patients With Diabetic Macular Edema Evaluating a Spaced Out Follow-up After Intensive Treatment Phase (CONSTELLATION)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02032173
Recruitment Status : Terminated
First Posted : January 9, 2014
Last Update Posted : June 11, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE January 8, 2014
First Posted Date  ICMJE January 9, 2014
Last Update Posted Date June 11, 2015
Study Start Date  ICMJE May 2014
Estimated Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 8, 2014)
Rate of patients with a stable BCVA at 24 months compared with BCVA at 6 months [ Time Frame: 6 months and 24 months ]
Best-Corrected Visual Acuity (BCVA) is measured using an Early Treatment of Diabetic Retinopathy Study scale (ETDRS scale) at 4m. The BCVA score at 6 and 24 months visits will be used. The rate of patients with a stable BCVA (BCVA score at 6 months minus BCVA score at 24 months ≤4 letters) will be calculated as well as its confidence interval at 95%
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02032173 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 9, 2014)
  • Rate of patients will a stable BCVA at 24 months compared with BCVA at 11 months [ Time Frame: month 11 and month 24 ]
    BCVA is measured using an ETDRS scale at 4m. The BCVA score at 11 and 24 months visits will be used. The rate of patients with a stable BCVA (BCVA score at 11 months minus BCVA score at 24 months ≤4 letters) will be calculated.
  • Rate of patients keeping a BCVA score gain ≥10 letters [ Time Frame: baseline, months 3, 6, 8, 11, 14, 17, 20, 23 and 24 ]
    The rates of patients with a BCVA score ≥10 letters for each of the following visits (months 3, 6, 8, 11, 14, 17, 20, 23 and 24) compared with baseline (day 0) will be calculated.
  • Rate of patients keeping a BCVA score gain ≥15 letters [ Time Frame: baseline, months 3, 6, 8, 11, 14, 17, 20, 23 and 24 ]
    The rates of patients with a BCVA score ≥15 letters for each of the following visits (months 3, 6, 8, 11, 14, 17, 20, 23 and 24) compared with baseline (day 0) will be calculated.
  • BCVA mean absolute variation from baseline to 24 months [ Time Frame: Baseline, months 1, 2, 3, 4, 5, 6, 8, 11, 14, 17, 20, 23 and 24 ]
    BCVA scores for all visits between baseline and month 24 from both main and rescue groups are recorded. The mean absolute variations are calculated from baseline score.
  • CST evaluation [ Time Frame: baseline, months 1, 2, 3, 4, 5, 6, 8, 11, 14, 17, 20, 23 and 24 ]
    The absolute variations of the Central Subfield Thickness (CST) measured using a Spectral Domain-Optical Coherence Tomography (SD-OCT) at each visit is calculated from baseline score and for both main and rescue groups. Values can also be calculated as a log OCT (=log[CST/200]).
  • Effect of follow-up change on CST and BCVA in rescue group [ Time Frame: months 6, 12, 18 and 24 ]
    Change of CST and BCVA score of patients from the rescue group.
  • Rate of patients with a BCVA loss ≥15 letters compared with month 6 [ Time Frame: Months 6, 8, 11, 14, 17, 20, 23 and 24 ]
    The rate of patients with a BCVA loss ≥15 letters compared with month 6 BCVA score leading to a change of group (Rescue group) evaluated from each visit onwards stating at month 6.
  • Number of participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: up month 24 ]
    Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs) directly reported by patients or by the physician during a study visit as well as systolic and diastolic blood pressure (absolute values and variation from baseline) will be reported.
  • Evaluation of the spaced out follow-up on visual functions and quality of life [ Time Frame: baseline, months 11, 12 and 24 ]
    The global score obtained on the Visual Function Questionnaire 25 (VFQ 25) will be compared from baseline to months 11 and 24 for the Main group and from baseline to months 12 and 24 for the Rescue group.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 8, 2014)
  • Rate of patients will a stable BCVA at 24 months compared with BCVA at 11 months [ Time Frame: month 11 and month 24 ]
    BCVA is measured using an ETDRS scale at 4m. The BCVA score at 11 and 24 months visits will be used. The rate of patients with a stable BCVA (BCVA score at 11 months minus BCVA score at 24 months ≤4 letters) will be calculated.
  • Rate of patients keeping a BCVA score gain ≥10 letters [ Time Frame: baseline, months 3, 6, 8, 11, 14, 17, 20, 23 and 24 ]
    The rates of patients with a BCVA score ≥10 letters for each of the following visits (months 3, 6, 8, 11, 14, 17, 20, 23 and 24) compared with baseline (day 0) will be calculated.
  • Rate of patients keeping a BCVA score gain ≥15 letters [ Time Frame: baseline, months 3, 6, 8, 11, 14, 17, 20, 23 and 24 ]
    The rates of patients with a BCVA score ≥15 letters for each of the following visits (months 3, 6, 8, 11, 14, 17, 20, 23 and 24) compared with baseline (day 0) will be calculated.
  • BCVA mean absolute variation from baseline to 24 months [ Time Frame: Baseline, months 1, 2, 3, 4, 5, 6, 8, 11, 14, 17, 20, 23 and 24 ]
    BCVA scores for all visits between baseline and month 24 from both main and rescue groups are recorded. The mean absolute variations are calculated from baseline score.
  • CST evaluation [ Time Frame: baseline, months 1, 2, 3, 4, 5, 6, 8, 11, 14, 17, 20, 23 and 24 ]
    The absolute variations of the Central Subfield Thickness (CST) measured using a Spectral Domain-Optical Coherence Tomography (SD-OCT) at each visit is calculated from baseline score and for both main and rescue groups. Values can also be calculated as a log OCT (=log[CST/200]).
  • Effect of follow-up change on CST and BCVA in rescue group [ Time Frame: months 6, 12, 18 and 24 ]
    Change of CST and BCVA score of patients from the rescue group.
  • Rate of patients with a BCVA loss ≥15 letters compared with month 6 [ Time Frame: Months 6, 8, 11, 14, 17, 20, 23 and 24 ]
    The rate of patients with a BCVA loss ≥15 letters compared with month 6 BCVA score leading to a change of group (Rescue group) evaluated from each visit onwards stating at month 6.
  • Number of participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: up month 24 ]
    Frequency of AEs and SAEs directly reported by patients or by the physician during a study visit as well as systolic and diastolic blood pressure (absolute values and variation from baseline) will be reported.
  • Evaluation of the spaced out follow-up on visual functions and quality of life [ Time Frame: baseline, months 11, 12 and 24 ]
    The global score obtained on the Visual Function Questionnaire 25 (VFQ 25) will be compared from baseline to months 11 and 24 for the Main group and from baseline to months 12 and 24 for the Rescue group.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Lucentis® Use in Patients With Diabetic Macular Edema Evaluating a Spaced Out Follow-up After Intensive Treatment Phase
Official Title  ICMJE 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
Brief Summary To evaluate a new treatment regimen with a spaced out follow-up after an initial intensive treatment phase in patients with reduced visual acuity due to diabetic macular edema (DME).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Macular Edema
  • Macular Degeneration
  • Diabetes
Intervention  ICMJE Drug: Main group
Patient will start in the main group with 6 monthly ranimizumab IVTs until month 5. Additional mandatory IVTs will be done at months 8 and 11. At months 14, 17, 20 and 23, IVTs will be done if BCVA loss is comprised between 9 and 5 letters (included). If patient did not loose more than 4 letters, no injection has to be performed at the visit. Criteria to stay in the main group are : 1°) at Month 3, 4 letters (included) improvement compared to baseline (Day 0) OR an improvement in CSF ≥ 0.1 log OCT compared to baseline (Day 0); 2°) at Month 6, a stable VA is obtained based on the months 4, 5 and 6 BCVA score; 3°) at Months 8, 11, 14, 17, 20 and 23, no BCVA decrease by more than 10 letters (excluded) compared with the highest BCVA score since the beginning of the study.
Study Arms  ICMJE Experimental: Main group
All patients enrolled in the study (155 patients) will start in this main group. They will receive 6 ranibizumab injections (one per month from baseline to month 5, 0.5 mg of ranibizumab per injection). After this intensive follow up phase, injection will be done every 3 months until month 24. If a patient does not meet the criteria to stay in the main group, he/she will be directed to the rescue group, where monitoring and treatment is recommended to be performed according to the SmPC of Lucentis® (ranibizumab) (PRN with monthly follow up)
Intervention: Drug: Main group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 10, 2015)
31
Original Estimated Enrollment  ICMJE
 (submitted: January 8, 2014)
155
Estimated Study Completion Date  ICMJE January 2018
Estimated Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02032173
Other Study ID Numbers  ICMJE CRFB002DFR11
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP