Efficacy and Safety of Ranibizumab 0.5 mg Administered as Two Alternative Dosing Regimens in Chinese Patients With nAMD (Age Related Macular Degeneration) - Clinical Trial for Neovascular Age-related Macular Degeneration | NCT01775124

Back to results

Primary Purpose

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Ranibizumab

About this trial

This is an interventional treatment trial for Neovascular Age-related Macular Degeneration focused on measuring Macular degeneration,, age-related macular degeneration (ARMD),, vision loss,, macula damage,, retina damage,, dry macular degeneration,, wet macular degeneration,, AMD

Eligibility Criteria

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

Key Inclusion criteria:

Patients with visual impairment due to neovascular AMD
A qualifying vision score at study entry Key Exclusion criteria
Active infection or inflammation either eye at study entry
Uncontrolled glaucoma in either eye
Any disorder in the study eye which may affect vision
Use of any systemic anti-vascular endothelial growth factor (VEGF)-drugs within 3 months prior to study entry
Previous treatment of the study eye for wet AMD
Any surgery in the study eye 3 months prior to or planned with 6 month after study entry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Ranibizumab 0.5 mg monthly

Ranibizumab 0.5 mg pro re nata (PRN)

Arm Description

Monthly intravitreal injections of ranibizumab 0.5 mg in the core treatment period and PRN intravitreal injections of the same dose guided by best-corrected visual acuity (BCVA) stabilization in the extension treatment period

PRN intravitreal injections of ranibizumab 0.5 mg guided by best-corrected visual acuity (BCVA) stabilization in the 23 month treatment period

Outcomes

Primary Outcome Measures

Average Change in Visual Acuity (Letters) From Month 3 to Month 4 Through Month 12

Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like VA testing charts at a testing distance of 4 meters. This outcome measure describes the difference between the VA averaged across all visits from Month 4 through 12 and the Month 3 Level of Visual Acuity (Letters) of the Study Eye. The treatment regimen up to Month 3 is the same in both treatment groups.

Secondary Outcome Measures

Average Visual Acuity Change (Letters) From Month 3 to Month 4 Through Month 24

Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes the difference between the average level of VA over all monthly post-baseline assessments from Month 4 to Month 24 and the Month 3 Level of VA. The treatment regimen up to Month 3 is the same in both treatment groups.

Average Visual Acuity Change From Baseline to Month 1 Through Month 12 and Month 1 Through Month 24

Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes the difference between VA averaged across all visits from Month 1 through Month 12 (24) and the baseline VA level

Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time

Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes the change in visual acuity at each visit compared to baseline

Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24

Visual acuity (VA) was at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes for each post-baseline month whether or not a patient improved by equal or more than 5, 10, 15,or 30 letters of VA as compared to baseline.

Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time

Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes for each post-baseline month whether or not a patient lost less than 15 letters of VA as compared with baseline.

Number of Patients With a Best Corrected Visual Acuity (BCVA) of More of 73 Letters or More

Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes for Month 12 and Month 24 whether a patient had a VA score of 73 or more letters

Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24

Optical coherence tomography(OCT) was used to assess CSFT (Central Sub-Field Thickness) representing the average retinal thickness of the circular area within 1 mm diameter around the foveal center. The Ns in the rows is the number of patients with a value for both baseline and the specific post-baseline visit

Duration of Ranibizumab Treatment Free Interval in the Study Eye up to Month 24

This outcome measure describes duration of treatment-free intervals. Treatment-free interval is defined as the number of visits (whether attended or not) where ranibizumab was not administered. n= the number of patients who had at least one ranibizumab treatment interruption

Duration of Ranibizumab Treatment Free Interval in the Study Eye Prior to Month 12

This outcome measure describes duration of treatment-free intervals prior to month 12. Treatment-free interval is defined as the number of visits (whether attended or not) where ranibizumab was not administered. n= the number of patients who had at least one ranibizumab treatment interruption Treatment-free interval is analyzed in the Ranibizumab 0.5 mg PRN group only. It is not analyzed in the Ranibizumab 0.5 mg monthly group because, by protocol design, these participants receive treatment monthly. Therefore, the analysis does not apply to this group.

Duration of Active Treatment Phase Prior to Month 12

Duration of Active Treatment Phase up to Month 24

Full Information

NCT ID

NCT01775124

First Posted

January 22, 2013

Last Updated

August 21, 2019

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01775124

Brief Title

Efficacy and Safety of Ranibizumab 0.5 mg Administered as Two Alternative Dosing Regimens in Chinese Patients With nAMD (Age Related Macular Degeneration)

Acronym

DRAGON

Official Title

A 24-month, Randomized, Double-masked, Controlled, Multicenter Study Evaluating the Efficacy and Safety of Ranibizumab 0.5 mg Administered as Two Alternative Dosing Regimens in Chinese Patients With Neovascular Age Related Macular Degeneration (AMD)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

February 22, 2013 (Actual)

Primary Completion Date

November 23, 2015 (Actual)

Study Completion Date

November 23, 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

The study evaluated the efficacy and safety of two different dosing regimens of ranibizumab (either monthly injections or injections as-needed based on the stability of a patient's vision) in Chinese patients with wet age-related macular degeneration (AMD) . This study was to provide long-term safety data in the treatment of Chinese patients with wet AMD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neovascular Age-related Macular Degeneration

Keywords

Macular degeneration,, age-related macular degeneration (ARMD),, vision loss,, macula damage,, retina damage,, dry macular degeneration,, wet macular degeneration,, AMD

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

332 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ranibizumab 0.5 mg monthly

Arm Type

Experimental

Arm Description

Monthly intravitreal injections of ranibizumab 0.5 mg in the core treatment period and PRN intravitreal injections of the same dose guided by best-corrected visual acuity (BCVA) stabilization in the extension treatment period

Arm Title

Ranibizumab 0.5 mg pro re nata (PRN)

Arm Type

Experimental

Arm Description

PRN intravitreal injections of ranibizumab 0.5 mg guided by best-corrected visual acuity (BCVA) stabilization in the 23 month treatment period

Intervention Type

Drug

Intervention Name(s)

Ranibizumab

Intervention Description

Intravitreal injections of 0.5 mg Ranibizumab

Primary Outcome Measure Information:

Title

Average Change in Visual Acuity (Letters) From Month 3 to Month 4 Through Month 12

Description

Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like VA testing charts at a testing distance of 4 meters. This outcome measure describes the difference between the VA averaged across all visits from Month 4 through 12 and the Month 3 Level of Visual Acuity (Letters) of the Study Eye. The treatment regimen up to Month 3 is the same in both treatment groups.

Time Frame

Month 3 to month 4 through Month 12

Secondary Outcome Measure Information:

Title

Average Visual Acuity Change (Letters) From Month 3 to Month 4 Through Month 24

Description

Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes the difference between the average level of VA over all monthly post-baseline assessments from Month 4 to Month 24 and the Month 3 Level of VA. The treatment regimen up to Month 3 is the same in both treatment groups.

Time Frame

Month 3 to month 4 through Month 24

Title

Average Visual Acuity Change From Baseline to Month 1 Through Month 12 and Month 1 Through Month 24

Description

Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes the difference between VA averaged across all visits from Month 1 through Month 12 (24) and the baseline VA level

Time Frame

Baseline to Month 24

Title

Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time

Description

Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes the change in visual acuity at each visit compared to baseline

Time Frame

Baseline to 24 months

Title

Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24

Description

Visual acuity (VA) was at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes for each post-baseline month whether or not a patient improved by equal or more than 5, 10, 15,or 30 letters of VA as compared to baseline.

Time Frame

Baseline to Month 24

Title

Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time

Description

Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes for each post-baseline month whether or not a patient lost less than 15 letters of VA as compared with baseline.

Time Frame

Baseline to Month 24

Title

Number of Patients With a Best Corrected Visual Acuity (BCVA) of More of 73 Letters or More

Description

Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes for Month 12 and Month 24 whether a patient had a VA score of 73 or more letters

Time Frame

Month 12 and 24

Title

Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24

Description

Optical coherence tomography(OCT) was used to assess CSFT (Central Sub-Field Thickness) representing the average retinal thickness of the circular area within 1 mm diameter around the foveal center. The Ns in the rows is the number of patients with a value for both baseline and the specific post-baseline visit

Time Frame

Baseline to Month 24

Title

Duration of Ranibizumab Treatment Free Interval in the Study Eye up to Month 24

Description

This outcome measure describes duration of treatment-free intervals. Treatment-free interval is defined as the number of visits (whether attended or not) where ranibizumab was not administered. n= the number of patients who had at least one ranibizumab treatment interruption

Time Frame

up to month 24

Title

Duration of Ranibizumab Treatment Free Interval in the Study Eye Prior to Month 12

Description

This outcome measure describes duration of treatment-free intervals prior to month 12. Treatment-free interval is defined as the number of visits (whether attended or not) where ranibizumab was not administered. n= the number of patients who had at least one ranibizumab treatment interruption Treatment-free interval is analyzed in the Ranibizumab 0.5 mg PRN group only. It is not analyzed in the Ranibizumab 0.5 mg monthly group because, by protocol design, these participants receive treatment monthly. Therefore, the analysis does not apply to this group.

Time Frame

prior to month 12

Title

Duration of Active Treatment Phase Prior to Month 12

Time Frame

Prior to month 12

Title

Duration of Active Treatment Phase up to Month 24

Time Frame

up to month 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Key Inclusion criteria: Patients with visual impairment due to neovascular AMD A qualifying vision score at study entry Key Exclusion criteria Active infection or inflammation either eye at study entry Uncontrolled glaucoma in either eye Any disorder in the study eye which may affect vision Use of any systemic anti-vascular endothelial growth factor (VEGF)-drugs within 3 months prior to study entry Previous treatment of the study eye for wet AMD Any surgery in the study eye 3 months prior to or planned with 6 month after study entry

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

Beijing

State/Province

Beijing

ZIP/Postal Code

100191

Country

China

Facility Name

Novartis Investigative Site

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100730

Country

China

Facility Name

Novartis Investigative Site

City

Chongqing City

State/Province

Chongqing

ZIP/Postal Code

400042

Country

China

Facility Name

Novartis Investigative Site

City

Lanzhou

State/Province

Gansu

ZIP/Postal Code

730030

Country

China

Facility Name

Novartis Investigative Site

City

Harbin

State/Province

Heilongjiang

ZIP/Postal Code

150001

Country

China

Facility Name

Novartis Investigative Site

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430060

Country

China

Facility Name

Novartis Investigative Site

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430070

Country

China

Facility Name

Novartis Investigative Site

City

Changsha City

State/Province

Hunan

ZIP/Postal Code

410011

Country

China

Facility Name

Novartis Investigative Site

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210029

Country

China

Facility Name

Novartis Investigative Site

City

Nanchang

State/Province

Jiangxi

ZIP/Postal Code

330006

Country

China

Facility Name

Novartis Investigative Site

City

Shenyang

State/Province

Liaoning

ZIP/Postal Code

110011

Country

China

Facility Name

Novartis Investigative Site

City

Qingdao

State/Province

Shandong

ZIP/Postal Code

2666000

Country

China

Facility Name

Novartis Investigative Site

City

Taiyuan

State/Province

Shanxi

ZIP/Postal Code

030002

Country

China

Facility Name

Novartis Investigative Site

City

Chengdu

State/Province

Sichuan

ZIP/Postal Code

610041

Country

China

Facility Name

Novartis Investigative Site

City

Tianjin

State/Province

Tianjin

ZIP/Postal Code

300020

Country

China

Facility Name

Novartis Investigative Site

City

Tianjin

State/Province

Tianjin

ZIP/Postal Code

300070

Country

China

Facility Name

Novartis Investigative Site

City

Wenzhou

State/Province

Zhejiang

ZIP/Postal Code

325027

Country

China

Facility Name

Novartis Investigative Site

City

Beijing

ZIP/Postal Code

100044

Country

China

Facility Name

Novartis Investigative Site

City

Beijing

ZIP/Postal Code

100176

Country

China

Facility Name

Novartis Investigative Site

City

Chongqing

ZIP/Postal Code

400038

Country

China

Facility Name

Novartis Investigative Site

City

Shanghai

ZIP/Postal Code

200031

Country

China

Facility Name

Novartis Investigative Site

City

Shanghai

ZIP/Postal Code

200080

Country

China

Facility Name

Novartis Investigative Site

City

Shanghai

ZIP/Postal Code

200092

Country

China

Efficacy and Safety of Ranibizumab 0.5 mg Administered as Two Alternative Dosing Regimens in Chinese Patients With nAMD (Age Related Macular Degeneration) (DRAGON)

Neovascular Age-related Macular Degeneration

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial