Ranibizumab Intravitreal Injections Versus Sham Control in Patients With Branch Retinal Vein Occlusion (BRVO) - Clinical Trial for Macular Edema Secondary to Branch Retinal Vein Occlusion | NCT01976338

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Ranibizumab 0.5 mg

Sham injection

About this trial

This is an interventional treatment trial for Macular Edema Secondary to Branch Retinal Vein Occlusion focused on measuring BRVO, macular edema, vision impairment, retinal vein occlusion, ranibizumab, branch retinal vein occlusion, anti-VEGF therapy, RFB002

Eligibility Criteria

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

Inclusion Criteria:

• Patients with visual impairment secondary to branch retinal vein occlusion (BRVO) with a BCVA between 19 and 73 letters in one eye and at least 35 letters in the other eye.

Exclusion Criteria:

Pregnant or nursing women or women of child bearing potential without unless using an effective contraception
Stroke or myocard infarction within 3 months prior to study
History of malignancy within the past 5 years
Uncontrolled hypertension
Active infection or inflammation in any eye
use of corticosteroids for at least 30 days in the last 6 months
treatment with anti-angiogenic drugs in any eye within last 3 months
Panretinal or focal/drid laser photocoagulation within the last few months

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Ranibizumab 0.5 mg

Sham injection

Arm Description

PRN Intravitreal injection

As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection

Outcomes

Primary Outcome Measures

Average Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 1 Through Month 6

Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. Mean Visual Acuity was averaged over all monthly assessments from month 1 to month 6 and compared to Baseline.

Secondary Outcome Measures

Average Change of Best Corrected Visual Acuity (BCVA) in Patients From Baseline to Month 1 Through Month 12

Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. Mean Visual Acuity was averaged over all monthly assessments from month 1 to month 12 and compared to Baseline

Best Corrected Visual Acuity (BCVA) Change Over Time

Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. Mean Visual Acuity was averaged over all monthly assessments from month 1 to month 12 and compared to Baseline

Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time

Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters

Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of 15 Letters in the Study Eye

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.

Change in Central-Sub-Field- Thickness (CSFT) Over Time

OCT (optical coherence tomography) 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

Change in Total Area of Fluorescein Leakage (Center Subfield) From Baseline Over Time

Fluorescein leakage area was assessed using Fluorescein angiography (FA) in conjunction with 7-field color fundus photography (CF) at Screening, Month 3, Month 6 and End of Study visit for both eyes

Change in Total Area of Fluorescein Leakage (Inner Subfield) From Baseline Over Time

Fluorescein leakage area was assessed using Fluorescein angiography (FA) in conjunction with 7-field color fundus photography (CF) at Screening, Month 3, Month 6 and End of Study visit for both eyes

Change in Total Area of Fluorescein Leakage (Outer Subfield) From Baseline Over Time

Fluorescein leakage area was assessed using Fluorescein angiography (FA) in conjunction with 7-field color fundus photography (CF) at Screening, Month 3, Month 6 and End of Study visit for both eyes

Change From Baseline in NEI-VFQ-25 Composite and Subscale Scores at Month 3, Month 6 and Month 12

The VFQ-25 consists of 25 vision related questions across 11 vision related subscales, including general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision and peripheral vision, and a general health rating. Items are converted to a 0-100 scale on each subscale and for the composite score where higher scores represents better functioning.

Full Information

NCT ID

NCT01976338

First Posted

October 18, 2013

Last Updated

March 27, 2017

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01976338

Brief Title

Ranibizumab Intravitreal Injections Versus Sham Control in Patients With Branch Retinal Vein Occlusion (BRVO)

Acronym

Blossom

Official Title

A Randomized Double-masked, Phase III Study Assessing Ranibizumab Intravitreal Injections Versus Sham Control in Patients With Visual Impairment Due to Macular Edema (ME) Secondary to Branch Retinal Vein Occlusion (BRVO) [Blossom]

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

November 12, 2013 (Actual)

Primary Completion Date

March 28, 2016 (Actual)

Study Completion Date

March 28, 2016 (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

Provided efficacy and safety data on intravitreal injections of ranibizumab 0.5 mg in patients with visual impairment due to macular edema secondary to BRVO

6. Conditions and Keywords

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

Macular Edema Secondary to Branch Retinal Vein Occlusion

Keywords

BRVO, macular edema, vision impairment, retinal vein occlusion, ranibizumab, branch retinal vein occlusion, anti-VEGF therapy, RFB002

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

283 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ranibizumab 0.5 mg

Arm Type

Experimental

Arm Description

PRN Intravitreal injection

Arm Title

Sham injection

Arm Type

Sham Comparator

Arm Description

As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection

Intervention Type

Drug

Intervention Name(s)

Ranibizumab 0.5 mg

Intervention Description

intravitreal injection of 0.05 ml

Intervention Type

Other

Intervention Name(s)

Sham injection

Other Intervention Name(s)

Sham

Intervention Description

Sham intravitreal injection

Primary Outcome Measure Information:

Title

Average Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 1 Through Month 6

Description

Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. Mean Visual Acuity was averaged over all monthly assessments from month 1 to month 6 and compared to Baseline.

Time Frame

Baseline to Month 1 through Month 6

Secondary Outcome Measure Information:

Title

Average Change of Best Corrected Visual Acuity (BCVA) in Patients From Baseline to Month 1 Through Month 12

Description

Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. Mean Visual Acuity was averaged over all monthly assessments from month 1 to month 12 and compared to Baseline

Time Frame

Baseline to Month 1 through Month 12

Title

Best Corrected Visual Acuity (BCVA) Change Over Time

Description

Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. Mean Visual Acuity was averaged over all monthly assessments from month 1 to month 12 and compared to Baseline

Time Frame

Month 1 through Month 12

Title

Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time

Description

Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters

Time Frame

Baseline to month 12

Title

Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of 15 Letters in the Study Eye

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 12 months

Title

Change in Central-Sub-Field- Thickness (CSFT) Over Time

Description

OCT (optical coherence tomography) 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

Time Frame

Month 1 to month 12

Title

Change in Total Area of Fluorescein Leakage (Center Subfield) From Baseline Over Time

Description

Fluorescein leakage area was assessed using Fluorescein angiography (FA) in conjunction with 7-field color fundus photography (CF) at Screening, Month 3, Month 6 and End of Study visit for both eyes

Time Frame

month 3, 6 and 12

Title

Change in Total Area of Fluorescein Leakage (Inner Subfield) From Baseline Over Time

Description

Fluorescein leakage area was assessed using Fluorescein angiography (FA) in conjunction with 7-field color fundus photography (CF) at Screening, Month 3, Month 6 and End of Study visit for both eyes

Time Frame

Months 3, 6 and 12

Title

Change in Total Area of Fluorescein Leakage (Outer Subfield) From Baseline Over Time

Description

Fluorescein leakage area was assessed using Fluorescein angiography (FA) in conjunction with 7-field color fundus photography (CF) at Screening, Month 3, Month 6 and End of Study visit for both eyes

Time Frame

Months 3, 6 and 12

Title

Change From Baseline in NEI-VFQ-25 Composite and Subscale Scores at Month 3, Month 6 and Month 12

Description

The VFQ-25 consists of 25 vision related questions across 11 vision related subscales, including general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision and peripheral vision, and a general health rating. Items are converted to a 0-100 scale on each subscale and for the composite score where higher scores represents better functioning.

Time Frame

Baseline, months 3, 6 and 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: • Patients with visual impairment secondary to branch retinal vein occlusion (BRVO) with a BCVA between 19 and 73 letters in one eye and at least 35 letters in the other eye. Exclusion Criteria: Pregnant or nursing women or women of child bearing potential without unless using an effective contraception Stroke or myocard infarction within 3 months prior to study History of malignancy within the past 5 years Uncontrolled hypertension Active infection or inflammation in any eye use of corticosteroids for at least 30 days in the last 6 months treatment with anti-angiogenic drugs in any eye within last 3 months Panretinal or focal/drid laser photocoagulation within the last few months

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

State/Province

Chongqing

ZIP/Postal Code

400042

Country

China

Facility Name

Novartis Investigative Site

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

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

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

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210006

Country

China

Facility Name

Novartis Investigative Site

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210029

Country

China

Facility Name

Novartis Investigative Site

City

Nantong

State/Province

Jiangsu

ZIP/Postal Code

226000

Country

China

Facility Name

Novartis Investigative Site

City

Nanchang

State/Province

Jiangxi

ZIP/Postal Code

330006

Country

China

Facility Name

Novartis Investigative Site

City

Qingdao

State/Province

Shandong

ZIP/Postal Code

266011

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

100034

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

400038

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

Facility Name

Novartis Investigative Site

City

Hongkong

Country

Hong Kong

Facility Name

Novartis Investigative Site

City

Bandung

State/Province

Jawa Barat

ZIP/Postal Code

40117

Country

Indonesia

Facility Name

Novartis Investigative Site

City

Jakarta

ZIP/Postal Code

10430

Country

Indonesia

Facility Name

Novartis Investigative Site

City

Manila

State/Province

Metro Manila

ZIP/Postal Code

1000

Country

Philippines

Facility Name

Novartis Investigative Site

City

San Juan City

ZIP/Postal Code

1500

Country

Philippines

Facility Name

Novartis Investigative Site

City

Kaohsiung

ZIP/Postal Code

83301

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Lin-Kou

ZIP/Postal Code

33305

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taipei

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Hanoi

ZIP/Postal Code

10000

Country

Vietnam

Facility Name

Novartis Investigative Site

City

Ho Chi Minh City

ZIP/Postal Code

70000

Country

Vietnam

12. IPD Sharing Statement

Citations:

PubMed Identifier

31902472

Citation

Wei W, Weisberger A, Zhu L, Cheng Y, Liu C; BLOSSOM Study Group. Efficacy and Safety of Ranibizumab in Asian Patients with Branch Retinal Vein Occlusion: Results from the Randomized BLOSSOM Study. Ophthalmol Retina. 2020 Jan;4(1):57-66. doi: 10.1016/j.oret.2019.08.001. Epub 2019 Aug 13.

Results Reference

derived

Ranibizumab Intravitreal Injections Versus Sham Control in Patients With Branch Retinal Vein Occlusion (BRVO) (Blossom)

Macular Edema Secondary to Branch Retinal Vein Occlusion

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