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A 12-month, Randomized, Efficacy and Safety Study of 0.5 mg Ranibizumab vs Laser in Chinese Diabetic Macular Edema (DME) Patients (REFINE)

Primary Purpose

Diabetic Macular Edema, Visual Impairment

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Ranibizumab (RFB002)

Laser

Sham injection

Sham laser

About this trial

This is an interventional treatment trial for Diabetic Macular Edema focused on measuring DME, macular edema, vision impairment, Chinese, diabetes

Eligibility Criteria

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

Key Inclusion Criteria:

Male or female Chinese patients ≥ 18 years of age with diabetes mellitus and with HbA1c ≤10.0%
Stable medication for diabetes within 3 months prior to Visit 1
Visual impairment due to DME with BCVA score between 78 and 39 letters as measured by ETDRS-like charts at 4 meters

Key Exclusion Criteria:

Stroke or myocardial infarction less than 3 months prior to screening visit
Uncontrolled hypertension
Active ocular infection or intraocular inflammation in any eye
Treatment with any anti-angiogenic drugs within 3 months prior to baseline visit in any eye
Active proliferative diabetic retinopathy in study eye
Use of other investigational drugs within 30 days and systemic anti-VEGF drugs within 6 months prior to baseline visit
Prior laser photocoagulation or intraocular procedure within 3 months prior to baseline in study eye
History of intravitreal corticosteroid treatment in phakic study eye, and in aphakic or pseudophakic within 3 months prior to screening

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ranibizumab (RFB002)

Laser

Arm Description

3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser

Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections

Outcomes

Primary Outcome Measures

Mean Average Change From Baseline in Best-Corrected Visual Acuity (BCVA) (Letters) to Month 1 Through 12

Visual acuity with eyeglasses was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at an initial testing distance of 4 meters. A letter score was calculated based on the number of letters correctly identified at the specified distance. Twelve monthly BCVA values were averaged [(Month1+Month2+...+Month12)/12], and the baseline BCVA value was subtracted from the average. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. One eye (study eye) contributed to the analysis.

Secondary Outcome Measures

Mean Change From Baseline in BCVA (Letters) at Each Visit

Visual acuity with eyeglasses was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at an initial testing distance of 4 meters. A letter score was calculated based on the number of letters correctly identified at the specified distance. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. One eye (study eye) contributed to the analysis.

Mean Change From Baseline in Central Sub-Field Thickness (CSFT) at Each Visit

CSFT (the average retinal thickness of the circular area within 1 millimeter diameter around the foveal center) was assessed using Optical Coherence Tomography (OCT). A negative change value indicates an improvement in macular edema, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis.

Percentage of Patients With BCVA Gain of ≥ 10 and ≥ 15 Letters From Baseline at Month 12

Visual acuity with eyeglasses was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at an initial testing distance of 4 meters. A letter score was calculated based on the number of letters correctly identified at the specified distance. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. One eye (study eye) contributed to the analysis.

Percentage of Patients With BCVA Loss of < 10 and < 15 Letters From Baseline to Month 12

Visual acuity with eyeglasses was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at an initial testing distance of 4 meters. A letter score was calculated based on the number of letters correctly identified at the specified distance. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. One eye (study eye) contributed to the analysis.

Percentage of Patients With BCVA ≥ 73 Letters at Month 12

Visual acuity with eyeglasses was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at an initial testing distance of 4 meters. A letter score was calculated based on the number of letters correctly identified at the specified distance. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. BCVA ≥ 73 letters is approximately equivalent to 20/40 on a Snellen chart. One eye (study eye) contributed to the analysis.

Mean Average Change in BCVA From Month 4 to Month 12 Compared to Month 3

Visual acuity with eyeglasses was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at an initial testing distance of 4 meters. A letter score was calculated based on the number of letters correctly identified at the specified distance. Nine monthly BCVA values were averaged [(Month4+Month5+...+Month12)/9],and the Month 3 BCVA value was subtracted from the average. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. One eye (study eye) contributed to the analysis.

Mean Change From Baseline in Patient-Reported Visual Functioning at Month 6 and Month 12, Composite Score

Visual functioning was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in visual functioning, while a negative change value indicates a worsening.

Mean Change From Baseline in Patient-Reported General Health at Month 6 and Month 12

General health was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in general health, while a negative change value indicates a worsening.

Mean Change From Baseline in Patient-Reported General Vision at Month 6 and Month 12

General vision was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in general vision, while a negative change value indicates a worsening.

Mean Change From Baseline in Patient-Reported Color Vision at Month 6 and Month 12

Color vision was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in color vision, while a negative change value indicates a worsening.

Mean Change From Baseline in Patient-Reported Peripheral Vision at Month 6 and Month 12

Peripheral vision was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in peripheral vision, while a negative change value indicates a worsening.

Mean Change From Baseline in Patient-Reported Ocular Pain at Month 6 and Month 12

Ocular pain was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in ocular pain, while a negative change value indicates a worsening.

Mean Change From Baseline in Patient-Reported Near Activities at Month 6 and Month 12

Near activities were assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in near activities, while a negative change value indicates a worsening.

Mean Change From Baseline in Patient-Reported Distance Activities at Month 6 and Month 12

Distance activities were assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in distance activities, while a negative change value indicates a worsening.

Mean Change From Baseline in Patient-Reported Social Functioning at Month 6 and Month 12

Social functioning was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in social functioning, while a negative change value indicates a worsening.

Mean Change From Baseline in Patient-Reported Mental Health at Month 6 and Month 12

Mental health was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in mental health, while a negative change value indicates a worsening.

Mean Change From Baseline in Patient-Reported Roles Difficulties at Month 6 and Month 12

Roles difficulties were assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in roles difficulties, while a negative change value indicates a worsening.

Mean Change From Baseline in Patient-Reported Dependency at Month 6 and Month 12

Dependency was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in dependency, while a negative change value indicates a worsening.

Mean Change From Baseline in Patient-Reported Driving at Month 6 and Month 12

Driving was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in driving, while a negative change value indicates a worsening. Note: Many patients did not answer the driving related question as they did not drive at all.

Mean Number of Ranibizumab Re-treatments Received in the Study Eye From Month 3 Onward

A ranibizumab re-treatment was defined as an administration of ranibizumab injection at a scheduled visit following at least one non-missed visit where ranibizumab was not administered in the study eye due to visual acuity stabilization. This outcome measure was pre-specified for the Ranibizumab 0.5 mg arm only.

Full Information

NCT ID

NCT02259088

First Posted

October 3, 2014

Last Updated

January 30, 2019

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02259088

Brief Title

A 12-month, Randomized, Efficacy and Safety Study of 0.5 mg Ranibizumab vs Laser in Chinese Diabetic Macular Edema (DME) Patients

Acronym

REFINE

Official Title

A 12-month, Randomized, Double-masked, Multicenter, Laser-controlled Phase III Study Assessing the Efficacy and Safety of 0.5 mg Ranibizumab Dosed PRN in Subjects With Visual Impairment Due to Diabetic Macular Edema in Chinese Patients

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

November 5, 2014 (Actual)

Primary Completion Date

January 17, 2017 (Actual)

Study Completion Date

January 17, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Study of efficacy and safety of 0.5 mg ranibizumab in Chinese patients with diabetic macular edema (DME)

Detailed Description

The purpose of this study was to provide efficacy and safety data on 0.5 mg ranibizumab intravitreal injections compared to laser photocoagulation in Chinese patients with visual impairment due to DME. Treatment was driven by achieving vision stabilization.

6. Conditions and Keywords

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

Diabetic Macular Edema, Visual Impairment

Keywords

DME, macular edema, vision impairment, Chinese, diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

384 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ranibizumab (RFB002)

Arm Type

Experimental

Arm Description

3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser

Arm Title

Laser

Arm Type

Active Comparator

Arm Description

Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections

Intervention Type

Drug

Intervention Name(s)

Ranibizumab (RFB002)

Other Intervention Name(s)

Lucentis

Intervention Description

Ranibizumab 0.5 mg/0.05 mL for intravitreal injection

Intervention Type

Procedure

Intervention Name(s)

Laser

Intervention Description

Laser photocoagulation according to Early Treatment Diabetic Retinopathy Study (ETDRS) guidelines

Intervention Type

Drug

Intervention Name(s)

Sham injection

Intervention Description

Imitation of an intravitreal injection consisting of an empty vial and an injection syringe without a needle

Intervention Type

Procedure

Intervention Name(s)

Sham laser

Intervention Description

Imitation of an active laser

Primary Outcome Measure Information:

Title

Mean Average Change From Baseline in Best-Corrected Visual Acuity (BCVA) (Letters) to Month 1 Through 12

Description

Time Frame

Baseline, Monthly from Month 1 through Month 12

Secondary Outcome Measure Information:

Title

Mean Change From Baseline in BCVA (Letters) at Each Visit

Description

Visual acuity with eyeglasses was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at an initial testing distance of 4 meters. A letter score was calculated based on the number of letters correctly identified at the specified distance. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. One eye (study eye) contributed to the analysis.

Time Frame

Baseline, Monthly from Month 1 through Month 12

Title

Mean Change From Baseline in Central Sub-Field Thickness (CSFT) at Each Visit

Description

Time Frame

Baseline, Monthly from Month 1 through Month 12

Title

Percentage of Patients With BCVA Gain of ≥ 10 and ≥ 15 Letters From Baseline at Month 12

Description

Visual acuity with eyeglasses was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at an initial testing distance of 4 meters. A letter score was calculated based on the number of letters correctly identified at the specified distance. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. One eye (study eye) contributed to the analysis.

Time Frame

Baseline, Month 12

Title

Percentage of Patients With BCVA Loss of < 10 and < 15 Letters From Baseline to Month 12

Description

Visual acuity with eyeglasses was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at an initial testing distance of 4 meters. A letter score was calculated based on the number of letters correctly identified at the specified distance. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. One eye (study eye) contributed to the analysis.

Time Frame

Baseline, Month 12

Title

Percentage of Patients With BCVA ≥ 73 Letters at Month 12

Description

Visual acuity with eyeglasses was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at an initial testing distance of 4 meters. A letter score was calculated based on the number of letters correctly identified at the specified distance. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. BCVA ≥ 73 letters is approximately equivalent to 20/40 on a Snellen chart. One eye (study eye) contributed to the analysis.

Time Frame

Month 12

Title

Mean Average Change in BCVA From Month 4 to Month 12 Compared to Month 3

Description

Visual acuity with eyeglasses was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at an initial testing distance of 4 meters. A letter score was calculated based on the number of letters correctly identified at the specified distance. Nine monthly BCVA values were averaged [(Month4+Month5+...+Month12)/9],and the Month 3 BCVA value was subtracted from the average. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. One eye (study eye) contributed to the analysis.

Time Frame

Monthly from Month 3 through Month 12

Title

Mean Change From Baseline in Patient-Reported Visual Functioning at Month 6 and Month 12, Composite Score

Description

Time Frame

Baseline, Month 6, Month 12

Title

Mean Change From Baseline in Patient-Reported General Health at Month 6 and Month 12

Description

Time Frame

Baseline, Month 6, Month 12

Title

Mean Change From Baseline in Patient-Reported General Vision at Month 6 and Month 12

Description

Time Frame

Baseline, Month 6, Month 12

Title

Mean Change From Baseline in Patient-Reported Color Vision at Month 6 and Month 12

Description

Time Frame

Baseline, Month 6, Month 12

Title

Mean Change From Baseline in Patient-Reported Peripheral Vision at Month 6 and Month 12

Description

Time Frame

Baseline, Month 6, Month 12

Title

Mean Change From Baseline in Patient-Reported Ocular Pain at Month 6 and Month 12

Description

Time Frame

Baseline, Month 6, Month 12

Title

Mean Change From Baseline in Patient-Reported Near Activities at Month 6 and Month 12

Description

Time Frame

Baseline, Month 6, Month 12

Title

Mean Change From Baseline in Patient-Reported Distance Activities at Month 6 and Month 12

Description

Time Frame

Baseline, Month 6, Month 12

Title

Mean Change From Baseline in Patient-Reported Social Functioning at Month 6 and Month 12

Description

Time Frame

Baseline, Month 6, Month 12

Title

Mean Change From Baseline in Patient-Reported Mental Health at Month 6 and Month 12

Description

Time Frame

Baseline, Month 6, Month 12

Title

Mean Change From Baseline in Patient-Reported Roles Difficulties at Month 6 and Month 12

Description

Time Frame

Baseline, Month 6, Month 12

Title

Mean Change From Baseline in Patient-Reported Dependency at Month 6 and Month 12

Description

Time Frame

Baseline, Month 6, Month 12

Title

Mean Change From Baseline in Patient-Reported Driving at Month 6 and Month 12

Description

Time Frame

Baseline, Month 6, Month 12

Title

Mean Number of Ranibizumab Re-treatments Received in the Study Eye From Month 3 Onward

Description

Time Frame

Monthly from Month 3 through Month 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: Male or female Chinese patients ≥ 18 years of age with diabetes mellitus and with HbA1c ≤10.0% Stable medication for diabetes within 3 months prior to Visit 1 Visual impairment due to DME with BCVA score between 78 and 39 letters as measured by ETDRS-like charts at 4 meters Key Exclusion Criteria: Stroke or myocardial infarction less than 3 months prior to screening visit Uncontrolled hypertension Active ocular infection or intraocular inflammation in any eye Treatment with any anti-angiogenic drugs within 3 months prior to baseline visit in any eye Active proliferative diabetic retinopathy in study eye Use of other investigational drugs within 30 days and systemic anti-VEGF drugs within 6 months prior to baseline visit Prior laser photocoagulation or intraocular procedure within 3 months prior to baseline in study eye History of intravitreal corticosteroid treatment in phakic study eye, and in aphakic or pseudophakic within 3 months prior to screening

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

100044

Country

China

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

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

Facility Name

Novartis Investigative Site

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510632

Country

China

Facility Name

Novartis Investigative Site

City

Shantou

State/Province

Guangdong

ZIP/Postal Code

515041

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

430022

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

State/Province

Hunan

ZIP/Postal Code

410011

Country

China

Facility Name

Novartis Investigative Site

City

Wuxi

State/Province

Jiangsu

Country

China

Facility Name

Novartis Investigative Site

City

Nanchang

State/Province

Jiangxi

ZIP/Postal Code

330019

Country

China

Facility Name

Novartis Investigative Site

City

Qingdao

State/Province

Shandong

ZIP/Postal Code

2666000

Country

China

Facility Name

Novartis Investigative Site

City

Xi'an

State/Province

Shanxi

ZIP/Postal Code

710032

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

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310003

Country

China

Facility Name

Novartis Investigative Site

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310014

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

100034

Country

China

Facility Name

Novartis Investigative Site

City

Beijing

ZIP/Postal Code

100050

Country

China

Facility Name

Novartis Investigative Site

City

Beijing

ZIP/Postal Code

100053

Country

China

Facility Name

Novartis Investigative Site

City

Beijing

ZIP/Postal Code

100176

Country

China

Facility Name

Novartis Investigative Site

City

Beijing

ZIP/Postal Code

100730

Country

China

Facility Name

Novartis Investigative Site

City

Chongqing

ZIP/Postal Code

400042

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

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Learn more about this trial

A 12-month, Randomized, Efficacy and Safety Study of 0.5 mg Ranibizumab vs Laser in Chinese Diabetic Macular Edema (DME) Patients

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A 12-month, Randomized, Efficacy and Safety Study of 0.5 mg Ranibizumab vs Laser in Chinese Diabetic Macular Edema (DME) Patients (REFINE)

Diabetic Macular Edema, Visual Impairment

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