VEGF Trap-Eye: Investigation of Efficacy and Safety in Ch... | NCT01482910

Status Module

Name	Class
Regeneron Pharmaceuticals	INDUSTRY

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Aflibercept injection (EYLEA, VEGF Trap-Eye, BAY86-5321)	Experimental	Participants received 2.0 mg intravitreal aflibercept injection (IAI) every 4 weeks for the first 12 weeks, followed by additional 2.0 mg IAI every 8 weeks until week 48. Additionally, sham photodynamic therapy (PDT) treatments was administered as needed.	Biological: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
PDT treatments	Active Comparator	Participants received PDT as needed. Additionally, sham IAI injections was administered until week 28. Thereafter, participants received active IAI treatment until week 48.	Drug: Visudyne

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)	Biological	Participants in the VEGF Trap-Eye group received intravitreal injections every 8 weeks following a loading phase with injections given every 4 weeks for an overall treatment period of 48 weeks. Additionally, sham PDT treatments was administered as needed.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS Letter Score at Week 28 - Last Observation Carried Forward (LOCF)	Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better functioning.	Baseline and at week 28

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants Who Lost Fewer Than 15 Letters at Week 28 - LOCF	Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better functioning.	At week 28

Eligibility Module

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)	Participants received 2.0 mg intravitreal aflibercept injection (IAI) every 4 weeks for the first 12 weeks, followed by additional 2.0 mg IAI every 8 weeks until week 48. Additionally, sham photodynamic therapy (PDT) treatments was administered as needed.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

ID	Title	Description
BG000	Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)	Participants received 2.0 mg intravitreal aflibercept injection (IAI) every 4 weeks for the first 12 weeks, followed by additional 2.0 mg IAI every 8 weeks until week 48. Additionally, sham photodynamic therapy (PDT) treatments was administered as needed.
BG001	PDT Treatments	Participants received PDT as needed. Additionally, sham IAI injections was administered until week 28. Thereafter, participants received active IAI treatment until week 48.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000228 BG00176 BG002304

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS Letter Score at Week 28 - Last Observation Carried Forward (LOCF)

Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better functioning.

Full analysis set

Posted

Mean

Standard Deviation

Letters correctly read

Baseline and at week 28

ID	Title	Description
OG000	Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)	Participants received 2.0 mg intravitreal aflibercept injection (IAI) every 4 weeks for the first 12 weeks, followed by additional 2.0 mg IAI every 8 weeks until week 48. Additionally, sham photodynamic therapy (PDT) treatments was administered as needed.
OG001	PDT Treatments	Participants received PDT as needed. Additionally, sham IAI injections was administered until week 28. Thereafter, participants received active IAI treatment until week 48.

Units	Counts
Participants	OG000228 OG00176

Title

Denominators

Categories

Title	Measurements
	OG00014.0± 12.1 OG0013.9± 14.6

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Null hypothesis: mean changes are identical in both groups. A sample size of 300 subjects with a 3:1 (EYLEA to PDT) randomization ratio is sufficient to detect the superiority of EYLEA to PDT assuming a two-sided alpha level of 0.05, a power of 90%, a treatment difference of 7.5 letters and a common standard deviation of 14 letters.	ANCOVA	ANCOVA with baseline BCVA as a covariate, and treatment group and baseline BCVA group (<45 letters vs ≥45 letters) as fixed factors	<0.0001	Hierarchical testing procedure was used in the order of pre-defined fixed sequence (primary endpoint first, then confirmatory secondary efficacy point next). A two-sided significance level of 0.05 was used.	Mean Difference (Final Values)	10.1			2-Sided	95	6.8	13.4

Secondary

Percentage of Participants Who Lost Fewer Than 15 Letters at Week 28 - LOCF

Full analysis set

Posted

Number

Percentage of participants

At week 28

ID	Title	Description
OG000	Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)	Participants received 2.0 mg intravitreal aflibercept injection (IAI) every 4 weeks for the first 12 weeks, followed by additional 2.0 mg IAI every 8 weeks until week 48. Additionally, sham photodynamic therapy (PDT) treatments was administered as needed.
OG001	PDT Treatments	Participants received PDT as needed. Additionally, sham IAI injections was administered until week 28. Thereafter, participants received active IAI treatment until week 48.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Aflibercept Injection, up to Week 28	Participants received 2.0 mg intravitreal aflibercept injection (IAI) every 4 weeks for the first 12 weeks, followed by additional 2.0 mg IAI every 8 weeks until week 48. Additionally, sham photodynamic therapy (PDT) treatments was administered as needed. The data up to week 28 was reported.	13	228	77	228
EG001	PDT Treatments, up to Week 28	Participants received PDT as needed. Additionally, sham IAI injections was administered until week 28. Thereafter, participants received active IAI treatment until week 48. The data up to week 28 was reported.	4	76	33	76
EG002	Aflibercept Injection, From Week 28 to Week 52	Participants received 2.0 mg intravitreal aflibercept injection (IAI) every 4 weeks for the first 12 weeks, followed by additional 2.0 mg IAI every 8 weeks until week 48. Additionally, sham photodynamic therapy (PDT) treatments was administered as needed. The data from week 28 up to week 52 was reported.	5	216	18	216
EG003	PDT Then Aflibercept Injection, From Week 28 to Week 52	Participants received PDT as needed. Additionally, sham IAI injections was administered until week 28. Thereafter, participants received active IAI treatment until week 48. The data from week 28 up to week 52 was reported.	3	71	9	71

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute myocardial infarction	Cardiac disorders	MedDRA (17.0)	Non-systematic Assessment	EG0000 affected228 at risk EG0010 affected76 at risk EG0020 affected216 at risk EG0031 affected71 at risk
Sudden hearing loss	Ear and labyrinth disorders	MedDRA (17.0)	Non-systematic Assessment	EG0000 affected228 at risk EG0010 affected76 at risk EG0021 affected216 at risk EG003
Cataract	Eye disorders	MedDRA (17.0)	Non-systematic Assessment	EG0000 affected228 at risk EG0010 affected76 at risk EG0020 affected216 at risk EG003
Visual acuity reduced	Eye disorders	MedDRA (17.0)	Non-systematic Assessment	EG0002 affected228 at risk EG0013 affected76 at risk EG0020 affected216 at risk EG003
Vitreous haemorrhage	Eye disorders	MedDRA (17.0)	Non-systematic Assessment	EG0000 affected228 at risk EG0010 affected76 at risk EG0021 affected216 at risk EG003
Gastric haemorrhage	Gastrointestinal disorders	MedDRA (17.0)	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected76 at risk EG0020 affected216 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA (17.0)	Non-systematic Assessment	EG0000 affected228 at risk EG0010 affected76 at risk EG0021 affected216 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA (17.0)	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected76 at risk EG0020 affected216 at risk EG003
Oesophageal polyp	Gastrointestinal disorders	MedDRA (17.0)	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected76 at risk EG0020 affected216 at risk EG003
Pneumonia	Infections and infestations	MedDRA (17.0)	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected76 at risk EG0020 affected216 at risk EG003
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA (17.0)	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected76 at risk EG0020 affected216 at risk EG003
Joint dislocation	Injury, poisoning and procedural complications	MedDRA (17.0)	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected76 at risk EG0020 affected216 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA (17.0)	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected76 at risk EG0020 affected216 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (17.0)	Non-systematic Assessment	EG0000 affected228 at risk EG0011 affected76 at risk EG0020 affected216 at risk EG003
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA (17.0)	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected76 at risk EG0020 affected216 at risk EG003
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA (17.0)	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected76 at risk EG0020 affected216 at risk EG003
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (17.0)	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected76 at risk EG0020 affected216 at risk EG003
Plasmacytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (17.0)	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected76 at risk EG0020 affected216 at risk EG003
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (17.0)	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected76 at risk EG0020 affected216 at risk EG003
Lung adenocarcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (17.0)	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected76 at risk EG0020 affected216 at risk EG003
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (17.0)	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected76 at risk EG0020 affected216 at risk EG003
Cerebral infarction	Nervous system disorders	MedDRA (17.0)	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected76 at risk EG0020 affected216 at risk EG003
Cerebral ischaemia	Nervous system disorders	MedDRA (17.0)	Non-systematic Assessment	EG0000 affected228 at risk EG0010 affected76 at risk EG0021 affected216 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (17.0)	Non-systematic Assessment	EG0001 affected228 at risk EG0010 affected76 at risk EG0020 affected216 at risk EG003
Hypertension	Vascular disorders	MedDRA (17.0)	Non-systematic Assessment	EG0000 affected228 at risk EG0010 affected76 at risk EG0021 affected216 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Conjunctival haemorrhage	Eye disorders	MedDRA (17.0)	Non-systematic Assessment	EG00014 affected228 at risk EG0014 affected76 at risk EG00213 affected216 at risk EG0034 affected71 at risk
Retinal haemorrhage	Eye disorders	MedDRA (17.0)	Non-systematic Assessment	EG0009 affected228 at risk EG0014 affected76 at risk EG0020 affected216 at risk EG003
Retinal pigment epitheliopathy	Eye disorders	MedDRA (17.0)	Non-systematic Assessment	EG00012 affected228 at risk EG0018 affected76 at risk EG0026 affected216 at risk EG003
Visual acuity reduced	Eye disorders	MedDRA (17.0)	Non-systematic Assessment	EG00016 affected228 at risk EG00111 affected76 at risk EG0026 affected216 at risk EG003
Subretinal fluid	Eye disorders	MedDRA (17.0)	Non-systematic Assessment	EG0002 affected228 at risk EG0014 affected76 at risk EG0022 affected216 at risk EG003
Macular fibrosis	Eye disorders	MedDRA (17.0)	Non-systematic Assessment	EG00027 affected228 at risk EG0018 affected76 at risk EG0026 affected216 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA (17.0)	Non-systematic Assessment	EG00010 affected228 at risk EG0014 affected76 at risk EG0026 affected216 at risk EG003
Intraocular pressure increased	Investigations	MedDRA (17.0)	Non-systematic Assessment	EG00012 affected228 at risk EG0012 affected76 at risk EG0022 affected216 at risk EG003

Facility	Status	City	State	ZIP	Country	Contacts
		Guangzhou	Guangdong	510060	China

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases

ID	Term
D011166	Porphyrins
D045725	Tetrapyrroles
D011758	Pyrroles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D006576	Heterocyclic Compounds, 4 or More Rings
D000072471	Heterocyclic Compounds, Fused-Ring
D047028	Macrocyclic Compounds
D011083	Polycyclic Compounds