Suprachoroidal Injection of Triamcinolone Acetonide With... | NCT03203447

Status 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
Active	Active Comparator	Lucentis (0.5 mg/0.05 mL), IVT injection + CLS-TA (4 mg/0.10 mL), SC injection or Avastin (1.25 mg/0.05 mL), IVT injection + CLS-TA (4 mg/0.10 mL), SC injection	Drug: suprachoroidal CLS-TA Drug: Lucentis or Avastin
Control	Sham Comparator	Lucentis (0.5 mg/0.05 mL), IVT injection + sham SC procedure or Avastin (1.25 mg/0.05 mL), IVT injection + sham SC procedure	Drug: suprachoroidal sham Drug: Lucentis or Avastin

Name	Type	Description	Arm Group Labels	Other Names
suprachoroidal CLS-TA	Drug	suprachoroidal injection of CLS-TA	Active

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS)	Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on an ETDRS eye chart. An increase from the pre-treatment state in BCVA of 15 letters or more represents a clinically meaningful improvement.	2 months

Secondary Outcomes

Measure	Description	Time Frame
Mean Change From Baseline in Best Corrected Visual Acuity	Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on an ETDRS eye chart. A positive change from baseline value represents an improvement in vision.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Thomas Ciulla, MD	Chief Medical Officer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Retinal Research Institute		Phoenix	Arizona	85053	United States
Retina Centers PC

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Active	Lucentis (0.5 mg/0.05 mL), IVT injection + CLS-TA (4 mg/0.10 mL), SC injection or Avastin (1.25 mg/0.05 mL), IVT injection + CLS-TA (4 mg/0.10 mL), SC injection suprachoroidal CLS-TA: suprachoroidal injection of CLS-TA Lucentis or Avastin: IVT anti-VEGF agent. Either a 0.5 mg intravitreal injection of Lucentis or 1.25 mg intravitreal injection of Avastin

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jan 25, 2018

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

Arm/Group Information

ID	Title	Description
BG000	Active	Lucentis (0.5 mg/0.05 mL), IVT injection + CLS-TA (4 mg/0.10 mL), SC injection or Avastin (1.25 mg/0.05 mL), IVT injection + CLS-TA (4 mg/0.10 mL), SC injection suprachoroidal CLS-TA: suprachoroidal injection of CLS-TA Lucentis or Avastin: IVT anti-VEGF agent. Either a 0.5 mg intravitreal injection of Lucentis or 1.25 mg intravitreal injection of Avastin
BG001	Control	Lucentis (0.5 mg/0.05 mL), IVT injection + sham SC procedure or Avastin (1.25 mg/0.05 mL), IVT injection + sham SC procedure suprachoroidal sham: sham suprachoroidal procedure Lucentis or Avastin: IVT anti-VEGF agent. Either a 0.5 mg intravitreal injection of Lucentis or 1.25 mg intravitreal injection of Avastin
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, Categorical

Age of patients in years relative to the date of the Screening visit.

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020
Between 18 and 65 years

Age, Continuous

Age of patients in years relative to the date of the Screening visit.

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00063.8± 13.07 BG00162.6± 12.26

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00079 BG00193 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

Hungary

Title	Measurements
	BG0002 BG0010 BG002

Type of Retinal Vein Occlusion

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Branch retinal vein occlusion	BG00090 BG00193 BG002

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

Proportion of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS)

Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on an ETDRS eye chart. An increase from the pre-treatment state in BCVA of 15 letters or more represents a clinically meaningful improvement.

The Intent-to-treat population included all randomized patients. Values for missing data were imputed using last observation carried forward.

Posted

Count of Participants

Participants

2 months

ID	Title	Description
OG000	Active	Lucentis (0.5 mg/0.05 mL), IVT injection + CLS-TA (4 mg/0.10 mL), SC injection or Avastin (1.25 mg/0.05 mL), IVT injection + CLS-TA (4 mg/0.10 mL), SC injection suprachoroidal CLS-TA: suprachoroidal injection of CLS-TA Lucentis or Avastin: IVT anti-VEGF agent. Either a 0.5 mg intravitreal injection of Lucentis or 1.25 mg intravitreal injection of Avastin
OG001	Control	Lucentis (0.5 mg/0.05 mL), IVT injection + sham SC procedure or Avastin (1.25 mg/0.05 mL), IVT injection + sham SC procedure suprachoroidal sham: sham suprachoroidal procedure Lucentis or Avastin: IVT anti-VEGF agent. Either a 0.5 mg intravitreal injection of Lucentis or 1.25 mg intravitreal injection of Avastin

Units	Counts
Participants	OG000162 OG001163

Title

Denominators

Categories

Title	Measurements
	OG00064 OG00176

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	Based on a Pearson chi-square test, a total sample size of approximately 460 subjects provided 90% power to detect a difference of 15% between the Active and Control arms assuming the Control arm showed a proportion of 0.50 at 8 weeks. The primary analysis was a test of superiority of the Active arm over the Control arm, and was based on a Cochran-Mantel-Haenszel chi-square test stratified by type of retinal vein occlusion.	Cochran-Mantel-Haenszel	The CMH test was stratified by the type of retinal vein occlusion, i.e., branch vs. central.	0.191	The a priori threshold for statistical significance was 0.050. Prior to evaluating the results of the CMH test, a Breslow-Day test with Tarone's adjustment was conducted to confirm the homogeneity of the odds ratios between RVO strata.	Difference in percentages	-7.1			2-Sided	95	-17.9	3.6

Secondary

Mean Change From Baseline in Best Corrected Visual Acuity

Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on an ETDRS eye chart. A positive change from baseline value represents an improvement in vision.

The Intent-to-treat population included all randomized subjects who received at least one study treatment. Values for missing data were not imputed.

Posted

Least Squares Mean

Standard Error

letters

6 months

ID	Title	Description
OG000	Active	Lucentis (0.5 mg/0.05 mL), IVT injection + CLS-TA (4 mg/0.10 mL), SC injection or Avastin (1.25 mg/0.05 mL), IVT injection + CLS-TA (4 mg/0.10 mL), SC injection suprachoroidal CLS-TA: suprachoroidal injection of CLS-TA Lucentis or Avastin: IVT anti-VEGF agent. Either a 0.5 mg intravitreal injection of Lucentis or 1.25 mg intravitreal injection of Avastin
OG001	Control	Lucentis (0.5 mg/0.05 mL), IVT injection + sham SC procedure or Avastin (1.25 mg/0.05 mL), IVT injection + sham SC procedure suprachoroidal sham: sham suprachoroidal procedure Lucentis or Avastin: IVT anti-VEGF agent. Either a 0.5 mg intravitreal injection of Lucentis or 1.25 mg intravitreal injection of Avastin

Secondary

Mean Change From Baseline in Central Subfield Thickness

Central subfield thickness (CST) is a diagnostic measurement used in identifying the presence of edema in the circular area 1 mm in diameter centered around the fovea. CST was measured using spectral domain optical coherence tomography (SD-OCT). A masked reading center graded the SD-OCT digital images. A negative change from baseline value represents a reduction in macular edema.

The Intent-to-treat population included all randomized subjects who received at least one study treatment. Values for missing data were not imputed.

Posted

Least Squares Mean

Standard Error

microns

6 months

ID	Title	Description
OG000	Active	Lucentis (0.5 mg/0.05 mL), IVT injection + CLS-TA (4 mg/0.10 mL), SC injection or Avastin (1.25 mg/0.05 mL), IVT injection + CLS-TA (4 mg/0.10 mL), SC injection suprachoroidal CLS-TA: suprachoroidal injection of CLS-TA Lucentis or Avastin: IVT anti-VEGF agent. Either a 0.5 mg intravitreal injection of Lucentis or 1.25 mg intravitreal injection of Avastin
OG001	Control	Lucentis (0.5 mg/0.05 mL), IVT injection + sham SC procedure or Avastin (1.25 mg/0.05 mL), IVT injection + sham SC procedure suprachoroidal sham: sham suprachoroidal procedure Lucentis or Avastin: IVT anti-VEGF agent. Either a 0.5 mg intravitreal injection of Lucentis or 1.25 mg intravitreal injection of Avastin

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Active	Lucentis (0.5 mg/0.05 mL), IVT injection + CLS-TA (4 mg/0.10 mL), SC injection or Avastin (1.25 mg/0.05 mL), IVT injection + CLS-TA (4 mg/0.10 mL), SC injection suprachoroidal CLS-TA: suprachoroidal injection of CLS-TA Lucentis or Avastin: IVT anti-VEGF agent. Either a 0.5 mg intravitreal injection of Lucentis or 1.25 mg intravitreal injection of Avastin	0	160	1	160	11	160
EG001	Control	Lucentis (0.5 mg/0.05 mL), IVT injection + sham SC procedure or Avastin (1.25 mg/0.05 mL), IVT injection + sham SC procedure suprachoroidal sham: sham suprachoroidal procedure Lucentis or Avastin: IVT anti-VEGF agent. Either a 0.5 mg intravitreal injection of Lucentis or 1.25 mg intravitreal injection of Avastin	0	162	3	162	1	162

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cardiac failure congestive	Cardiac disorders	MedDRA (19.0)	Non-systematic Assessment	EG0001 events1 affected160 at risk EG0010 events0 affected162 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (19.0)	Non-systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected162 at risk
Urinary tract infection	Infections and infestations	MedDRA (19.0)	Non-systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected162 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (19.0)	Non-systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected162 at risk
Mental status changes	Psychiatric disorders	MedDRA (19.0)	Non-systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected162 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Non-systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected162 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Non-systematic Assessment	EG0001 events1 affected160 at risk EG0010 events0 affected162 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (19.0)	Non-systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected162 at risk

Certain Agreements

Ancestor Terms

ID	Term
D014221	Triamcinolone
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D013259	Steroids, Fluorinated
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

ID	Term
D008268	Macular Degeneration
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases
D020246	Venous Thrombosis
D013927	Thrombosis
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D014222	Triamcinolone Acetonide
D000069579	Ranibizumab
D000068258	Bevacizumab