UNcovering the Difference Between Ranibizumab and Afliber... | NCT01988662

NCT01988662

ID	Type	Description	Link
2013-003482-34	EudraCT Number

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ranibizumab	Experimental	104 patients with an eligible study eye were randomized to be treated with Ranibizumab IVT. 0.5 mg of commercially available Ranibizumab were used for intravitreal injection adminstered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).	Procedure: Neovascular Age-related Macular Degeneration
Aflibercept	Active Comparator	101 patients with an eligible study eye were randomized to be treated with Aflibercept IVT. 2.0 mg of commercially available Aflibercept were used for intravitreal injection admistered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).	Procedure: Neovascular Age-related Macular Degeneration

Name	Type	Description	Arm Group Labels	Other Names
Neovascular Age-related Macular Degeneration	Procedure	Blood measurement	Aflibercept Ranibizumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent Change From Baseline at Month 3 in Plasma VEGF Following Intravitreal (IVT) Injection of Anti-VEGF Agent	Percent change in blood VEGF level is calculated as the difference in blood VEGF level measured after 3 month of anti-VEGF agent IVT treatment (Ranibizumab or Aflibercept) when compared to baseline blood VEGF level.	Change from baseline at Month 3

Secondary Outcomes

Measure	Description	Time Frame
Percent Change From Baseline in Plasma VEGF Level Overtime	Plasma VEGF measurement performed at all visits and compared to baseline level	Change from baseline up to month 3
Correlation Between Percent Change From Baseline Plasma VEGF Level and the Serum Anti-VEGF Agent Overtime

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Beersheba		84101	Israel
Novartis Investigative Site

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Ranibizumab	104 patients with an eligible study eye were randomized to be treated with Ranibizumab IVT. 0.5 mg of commercially available Ranibizumab were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Ranibizumab	104 patients with an eligible study eye were randomized to be treated with Ranibizumab IVT. 0.5 mg of commercially available Ranibizumab were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
BG001	Aflibercept	101 patients with an eligible study eye were randomized to be treated with Aflibercept IVT. 2.0 mg of commercially available Aflibercept were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Baseline (post-IVT injection; n=104, 100)

Title	Measurements
	OG00011.93± 5.836 OG001-9.37± 6.100

Week 1 (n=103, 101)

Title	Measurements
	OG000

Secondary

Correlation Between Percent Change From Baseline Plasma VEGF Level and the Serum Anti-VEGF Agent Overtime

VEGF level and anti-VEGF concentration measured in the blood at each single visit, including pre- and post-dose measurement at the dosing visits.

FAS

Posted

Number

95% Confidence Interval

pearson correlation coefficient

pre-dose to post-dose at Baseline, week 1, week 2, month 1, month 2, and month 3

ID	Title	Description
OG000	Ranibizumab	104 patients with an eligible study eye were randomized to be treated with Ranibizumab IVT. 0.5 mg of commercially available Ranibizumab were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
OG001	Aflibercept	101 patients with an eligible study eye were randomized to be treated with Aflibercept IVT. 2.0 mg of commercially available Aflibercept were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).

Units	Counts
Participants

Secondary

Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) of the Study Eye Over Time

BCVA score is assessed on study eye based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity charts at a testing distance of 4 meters. An increase in score indicates an improvement in acuity. Change from baseline calculated as observed post-baseline value - baseline value.

Posted

Mean

Standard Deviation

Letter

Baseline, month 1, month 2, month 3

ID	Title	Description
OG000	Ranibizumab	104 patients with an eligible study eye were randomized to be treated with Ranibizumab IVT. 0.5 mg of commercially available Ranibizumab were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
OG001	Aflibercept	101 patients with an eligible study eye were randomized to be treated with Aflibercept IVT. 2.0 mg of commercially available Aflibercept were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).

Secondary

Mean Change From Baseline in Central Retinal Thickness (CRT) of the Study Eye Over Time

CRT in micrometers assessed by Optical Tomography (OCT) at each single study visit. A reduction is thickness indicates an improvement is the lesion area.

Change from baseline calculated as observed post-baseline - baseline value.

Posted

Mean

Standard Deviation

micrometers

Baseline, month 1, month 2, month 3

ID	Title	Description
OG000	Ranibizumab	104 patients with an eligible study eye were randomized to be treated with Ranibizumab IVT. 0.5 mg of commercially available Ranibizumab were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
OG001	Aflibercept	101 patients with an eligible study eye were randomized to be treated with Aflibercept IVT. 2.0 mg of commercially available Aflibercept were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).

Secondary

Number of Patients With Ocular and Systemic Adverse Events

The incidence of reported treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAE).

Safety (SAF) analysis set: The SAF analysis set included all patients who received at least one dose of study treatment and had at least one post-baseline safety assessment.

Posted

Number

Participants

Day 1 to day 85

ID	Title	Description
OG000	Ranibizumab	104 patients with an eligible study eye were randomized to be treated with Ranibizumab IVT. 0.5 mg of commercially available Ranibizumab were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
OG001	Aflibercept	101 patients with an eligible study eye were randomized to be treated with Aflibercept IVT. 2.0 mg of commercially available Aflibercept were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).

Units	Counts
Participants

Primary

Percent Change From Baseline at Month 3 in Plasma VEGF Following Intravitreal (IVT) Injection of Anti-VEGF Agent

Percent change in blood VEGF level is calculated as the difference in blood VEGF level measured after 3 month of anti-VEGF agent IVT treatment (Ranibizumab or Aflibercept) when compared to baseline blood VEGF level.

Full Analysis Set (FAS): The FAS consisted of all randomized patients who received at least one dose of study treatment. FAS was the analysis set. However, patients who were randomized due to erroneous use of the IRT system and who did not receive at least one dose of study treatment were excluded from the FAS.

Posted

Least Squares Mean

Standard Error

Percent change

Change from baseline at Month 3

ID	Title	Description
OG000	Ranibizumab	104 patients with an eligible study eye were randomized to be treated with Ranibizumab IVT. 0.5 mg of commercially available Ranibizumab were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
OG001	Aflibercept	101 patients with an eligible study eye were randomized to be treated with Aflibercept IVT. 2.0 mg of commercially available Aflibercept were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Ranibizumab	104 patients with an eligible study eye were randomized to be treated with Ranibizumab IVT. 0.5 mg of commercially available Ranibizumab were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).	3	104	20	104
EG001	Aflibercept	101 patients with an eligible study eye were randomized to be treated with Aflibercept IVT. 2.0 mg of commercially available Aflibercept were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).	5	101	19	101
EG002	Total		8	205	39	205

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Retinal haemorrhage	Eye disorders	18.0	Systematic Assessment	EG0001 affected104 at risk EG0011 affected101 at risk EG0022 affected205 at risk
Vitreous haemorrhage	Eye disorders	18.0	Systematic Assessment	EG0001 affected104 at risk EG0010 affected101 at risk EG0021 affected205 at risk
Bronchitis	Infections and infestations	18.0	Systematic Assessment	EG0000 affected104 at risk EG0011 affected101 at risk EG0021 affected205 at risk
Rib fracture	Injury, poisoning and procedural complications	18.0	Systematic Assessment	EG0001 affected104 at risk EG0010 affected101 at risk EG0021 affected205 at risk
Neck pain	Musculoskeletal and connective tissue disorders	18.0	Systematic Assessment	EG0000 affected104 at risk EG0011 affected101 at risk EG0021 affected205 at risk
Headache	Nervous system disorders	18.0	Systematic Assessment	EG0000 affected104 at risk EG0011 affected101 at risk EG0021 affected205 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	18.0	Systematic Assessment	EG0000 affected104 at risk EG0011 affected101 at risk EG0021 affected205 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Conjunctival haemorrhage	Eye disorders	18.0	Systematic Assessment	EG0008 affected104 at risk EG0018 affected101 at risk EG00216 affected205 at risk
Conjunctival hyperaemia	Eye disorders	18.0	Systematic Assessment	EG0002 affected104 at risk EG0011 affected101 at risk EG0023 affected205 at risk
Dry eye	Eye disorders	18.0	Systematic Assessment	EG0003 affected104 at risk EG0011 affected101 at risk EG0024 affected205 at risk
Eye inflammation	Eye disorders	18.0	Systematic Assessment	EG0002 affected104 at risk EG0010 affected101 at risk EG0022 affected205 at risk
Eye pain	Eye disorders	18.0	Systematic Assessment	EG0004 affected104 at risk EG0013 affected101 at risk EG0027 affected205 at risk
Punctate keratitis	Eye disorders	18.0	Systematic Assessment	EG0003 affected104 at risk EG0012 affected101 at risk EG0025 affected205 at risk
Visual acuity reduced	Eye disorders	18.0	Systematic Assessment	EG0002 affected104 at risk EG0012 affected101 at risk EG0024 affected205 at risk
Vitreous floaters	Eye disorders	18.0	Systematic Assessment	EG0002 affected104 at risk EG0012 affected101 at risk EG0024 affected205 at risk
Sensation of foreign body	General disorders	18.0	Systematic Assessment	EG0003 affected104 at risk EG0011 affected101 at risk EG0024 affected205 at risk
Nasopharyngitis	Infections and infestations	18.0	Systematic Assessment	EG0001 affected104 at risk EG0012 affected101 at risk EG0023 affected205 at risk
Blood pressure increased	Investigations	18.0	Systematic Assessment	EG0002 affected104 at risk EG0012 affected101 at risk EG0024 affected205 at risk
Intraocular pressure increased	Investigations	18.0	Systematic Assessment	EG0000 affected104 at risk EG0012 affected101 at risk EG0022 affected205 at risk
Dizziness	Nervous system disorders	18.0	Systematic Assessment	EG0000 affected104 at risk EG0012 affected101 at risk EG0022 affected205 at risk
Headache	Nervous system disorders	18.0	Systematic Assessment	EG0003 affected104 at risk EG0010 affected101 at risk EG0023 affected205 at risk
Rash	Skin and subcutaneous tissue disorders	18.0	Systematic Assessment	EG0000 affected104 at risk EG0012 affected101 at risk EG0022 affected205 at risk
Urticaria	Skin and subcutaneous tissue disorders	18.0	Systematic Assessment	EG0002 affected104 at risk EG0010 affected101 at risk EG0022 affected205 at risk

ID	Term
C535598	Creatine deficiency, X-linked

ID	Term
D000069579	Ranibizumab
C533178	aflibercept

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins

Units	Counts
Participants	OG000104 OG001101

Units	Counts
Participants	OG000100 OG00199