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
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Macular Edema
Macular Degeneration
Diabetes
Keywords: Ranibizumab
Diabetic Macular Edema
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2014-01-09
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study was designed to assess the efficacy and safety of Lucentis® (ranibizumab 0.5 mg) in diabetic patients presenting with reduced visual acuity due to diabetic macular edema and evaluating spacing out of follow-up after initial intensive treatment phase.

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.

Eligibility 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

Primary outcomes:
measure: Number of Participants With a Stable BCVA in the Study Eye at 24 Months Compared With BCVA at 6 Months
timeFrame: Month 6 and 24
Secondary outcomes:
measure: Number of Participants With a Stable BCVA in the Study Eye at 24 Months Compared With BCVA at 11 Months
timeFrame: Month 11 and 24
measure: Visual Acuity: Number of Participants Keeping a BCVA Score Gain ≥10 Letters
timeFrame: Baseline, Month 3, 6, 8 and 11
measure: Visual Acuity: Number of Participants Keeping a BCVA Score Gain ≥15 Letters
timeFrame: Baseline, Months 3, 6, 8 and 11
measure: Visual Acuity: Number of Participants With a BCVA Loss ≥15 Letters at Months 8 and 11 Compared to Month 6 in the Study Eye.
timeFrame: Months 6, 8 and 11
measure: Visual Acuity : Change of BCVA From Baseline in the Study Eye (ETDRS)
timeFrame: Baseline, months 1, 2, 3, 4, 5, 6, 8 and 11
measure: Central Retinal Thickness : Change of Log OCT From Baseline in the Study Eye
timeFrame: Baseline, months 1, 2, 3, 4, 5, 6, 8 and 11
measure: Visual Acuity : Change of BCVA From Baseline in the Study Eye (ETDRS) - Rescue Group
timeFrame: Baseline, Months 3, 6, 8 and 11
measure: Central Retinal Thickness : Change of Log OCT From Baseline in the Study Eye - Rescue Group
timeFrame: Baseline, Months 3, 6, 8 and 11
measure: Evaluation of the Spaced Out Follow-up on Visual Functions and Quality of Life
timeFrame: baseline, months 11, 12 and 24
Other outcomes:
Locations:
city: Bobigny cedex
country: France
facility: Novartis Investigative Site
state: Seine Saint Denis
city: Bordeaux Cedex
country: France
facility: Novartis Investigative Site
city: Bordeaux
country: France
facility: Novartis Investigative Site
city: Creteil
country: France
facility: Novartis Investigative Site
city: Le Kremlin Bicetre Cedex
country: France
facility: Novartis Investigative Site
city: Lyon
country: France
facility: Novartis Investigative Site
city: Nice
country: France
facility: Novartis Investigative Site
city: Paris Cedex 19
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Poitiers
country: France
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: