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To Assess the Efficacy and Safety of Intravitreal Ranibizumab in People With Vision Loss Due to Macular Edema

Primary Purpose

Macular Edema (ME)

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Sham control
Ranibizumab
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Edema (ME) focused on measuring Vision Impairment

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Ranibizumab

Sham control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Change From Baseline in Central Subfield Volume (CSFV) in Study Eye
CSFV was assessed OCT. A negative change from baseline indicates improvement.
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.
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.
Number of Participants With Presence of Active Macular Edema (ME) Leakage
The presence of active ME leakage was assessed by fluorescein angiography (FA).
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.
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.
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.
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.
Number of Participants With Ranibizumab Treatments
The number of participants administered study treatments, according to treatment frequency, was assessed.
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.
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.

Full Information

First Posted
April 30, 2013
Last Updated
April 14, 2016
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01846299
Brief Title
To Assess the Efficacy and Safety of Intravitreal Ranibizumab in People With Vision Loss Due to Macular Edema
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Edema (ME)
Keywords
Vision Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
181 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ranibizumab
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham control
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Sham control
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Intervention Description
Ranibizumab 0.5mg/0.5mL was administered intravitreally to the participant.
Primary Outcome Measure Information:
Title
Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye
Description
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.
Time Frame
Baseline, Month 2
Secondary Outcome Measure Information:
Title
Change From Baseline in BCVA in Study Eye up to Month 2
Description
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.
Time Frame
Baseline, Month 1, Month 2
Title
Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye
Description
CSFT wasassessed by optical coherence tomography (OCT). A negative change from baseline indicates improvement.
Time Frame
Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Title
Change From Baseline in Central Subfield Volume (CSFV) in Study Eye
Description
CSFV was assessed OCT. A negative change from baseline indicates improvement.
Time Frame
Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Title
Number of Participants With Presence or Absence of Intra-retinal Fluid in Study Eye Compared to Baseline
Description
The presence of intra-retinal fluid was assessed by OCT.
Time Frame
Month 2, Month 6, Month 12
Title
Number of Participants With Presence or Absence of Subretinal Fluid in Study Eye Compared to Baseline
Description
The presence of subretinal fluid was assessed by OCT.
Time Frame
Month 2, Month 6, Month 12
Title
Number of Participants With Presence of Active Macular Edema (ME) Leakage
Description
The presence of active ME leakage was assessed by fluorescein angiography (FA).
Time Frame
Month 2
Title
Number of Participants Requiring Rescue Treatment at Month 1
Description
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.
Time Frame
Month 1
Title
Average Change From Baseline in BCVA
Description
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.
Time Frame
Baseline (BL), month 1 through month 6, month 1 through month 12
Title
Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters
Description
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.
Time Frame
Month 2, Month 6 , Month 12
Title
Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss
Description
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.
Time Frame
Month 2, Month 6, Month 12
Title
Number of Participants With Ranibizumab Treatments
Description
The number of participants administered study treatments, according to treatment frequency, was assessed.
Time Frame
Month 12
Title
Number of Participants With Re-treatments
Description
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.
Time Frame
Month 6, month 12
Title
Number of Primary Reasons for Decision to Treat by Investigator
Description
The total number of primary reasons for decisions to treat was assessed. A single participant could have had multiple primary reasons for treatment.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2000
Country
Australia
Facility Name
Novartis Investigative Site
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Novartis Investigative Site
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Novartis Investigative Site
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Facility Name
Novartis Investigative Site
City
South Launceston
State/Province
Tasmania
ZIP/Postal Code
7249
Country
Australia
Facility Name
Novartis Investigative Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Novartis Investigative Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2E1
Country
Canada
Facility Name
Novartis Investigative Site
City
Plzen
ZIP/Postal Code
301 00
Country
Czech Republic
Facility Name
Novartis Investigative Site
City
Praha 10
ZIP/Postal Code
100 34
Country
Czech Republic
Facility Name
Novartis Investigative Site
City
Bordeaux Cedex
ZIP/Postal Code
F-33076
Country
France
Facility Name
Novartis Investigative Site
City
Lyon
ZIP/Postal Code
69003
Country
France
Facility Name
Novartis Investigative Site
City
Paris cedex 10
ZIP/Postal Code
75010
Country
France
Facility Name
Novartis Investigative Site
City
Saint-Jean
ZIP/Postal Code
31240
Country
France
Facility Name
Novartis Investigative Site
City
Duesseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Novartis Investigative Site
City
Freiburg i. Br
ZIP/Postal Code
79106
Country
Germany
Facility Name
Novartis Investigative Site
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Novartis Investigative Site
City
Regensburg
ZIP/Postal Code
93042
Country
Germany
Facility Name
Novartis Investigative Site
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Novartis Investigative Site
City
Budapest
ZIP/Postal Code
1133
Country
Hungary
Facility Name
Novartis Investigative Site
City
Debrecen
ZIP/Postal Code
4012
Country
Hungary
Facility Name
Novartis Investigative Site
City
Szeged
ZIP/Postal Code
H-6720
Country
Hungary
Facility Name
Novartis Investigative Site
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Novartis Investigative Site
City
Kfar-Sava
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Novartis Investigative Site
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Novartis Investigative Site
City
Rehovot
ZIP/Postal Code
7610001
Country
Israel
Facility Name
Novartis Investigative Site
City
Tel-Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Novartis Investigative Site
City
Firenze
State/Province
FI
ZIP/Postal Code
50134
Country
Italy
Facility Name
Novartis Investigative Site
City
Genova
State/Province
GE
ZIP/Postal Code
16132
Country
Italy
Facility Name
Novartis Investigative Site
City
Milano
State/Province
MI
ZIP/Postal Code
20123
Country
Italy
Facility Name
Novartis Investigative Site
City
Pisa
State/Province
PI
ZIP/Postal Code
56124
Country
Italy
Facility Name
Novartis Investigative Site
City
Roma
State/Province
RM
ZIP/Postal Code
00133
Country
Italy
Facility Name
Novartis Investigative Site
City
Torino
State/Province
TO
ZIP/Postal Code
10122
Country
Italy
Facility Name
Novartis Investigative Site
City
Seoul
State/Province
Korea
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
State/Province
Korea
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Busan
ZIP/Postal Code
602-739
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
150-034
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Riga
ZIP/Postal Code
1002
Country
Latvia
Facility Name
Novartis Investigative Site
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Tilburg
ZIP/Postal Code
NL-5022GC
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Kazan
ZIP/Postal Code
420012
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Moscow
ZIP/Postal Code
119021
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Moscow
ZIP/Postal Code
127486
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Singapore
ZIP/Postal Code
168751
Country
Singapore
Facility Name
Novartis Investigative Site
City
Banska Bystrica
ZIP/Postal Code
97517
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Trencin
ZIP/Postal Code
91171
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Malaga
State/Province
Andalucia
ZIP/Postal Code
29010
Country
Spain
Facility Name
Novartis Investigative Site
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Novartis Investigative Site
City
Valladolid
State/Province
Castilla y Leon
ZIP/Postal Code
47011
Country
Spain
Facility Name
Novartis Investigative Site
City
Sant Cugat
State/Province
Catalunya
ZIP/Postal Code
08190
Country
Spain
Facility Name
Novartis Investigative Site
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Novartis Investigative Site
City
Binningen
ZIP/Postal Code
4102
Country
Switzerland
Facility Name
Novartis Investigative Site
City
Zuerich
ZIP/Postal Code
8063
Country
Switzerland
Facility Name
Novartis Investigative Site
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Novartis Investigative Site
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Facility Name
Novartis Investigative Site
City
Frimley
State/Province
Surrey
ZIP/Postal Code
GU16 7UJ
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Birmingham
ZIP/Postal Code
B18 7QU
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Bristol
ZIP/Postal Code
BS1 2LX
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
London
ZIP/Postal Code
EC1V 2PD
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Sunderland
ZIP/Postal Code
SR2 9HP
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

To Assess the Efficacy and Safety of Intravitreal Ranibizumab in People With Vision Loss Due to Macular Edema

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