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

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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 )

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).

Condition or disease Intervention/treatment Phase
Macular Edema Macular Degeneration Diabetes Drug: Main group Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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 Start Date : May 2014
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
Drug Information available for: Ranibizumab

Arm Intervention/treatment
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)
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.




Primary Outcome Measures :
  1. 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%


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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]).

  6. 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.

  7. 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.

  8. 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.

  9. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02032173


Locations
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France
Novartis Investigative Site
Bobigny, France, 93009
Novartis Investigative Site
Bordeaux Cedex, France, F-33076
Novartis Investigative Site
Bordeaux, France, 33000
Novartis Investigative Site
Créteil, France, 94000
Novartis Investigative Site
Le Kremlin Bicetre Cedex, France, 94275
Novartis Investigative Site
Lyon, France, 69003
Novartis Investigative Site
Nice, France, 6 000
Novartis Investigative Site
Paris Cedex 19, France, 75940
Novartis Investigative Site
Paris, France, 75015
Novartis Investigative Site
Poitiers, France, 86021
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02032173     History of Changes
Other Study ID Numbers: CRFB002DFR11
First Posted: January 9, 2014    Key Record Dates
Last Update Posted: June 11, 2015
Last Verified: June 2015
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Ranibizumab
Diabetic Macular Edema
Additional relevant MeSH terms:
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Macular Degeneration
Macular Edema
Edema
Signs and Symptoms
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents