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Completed

NCT Number: NCT01976338

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

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

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Key information

Conditions

Macular Edema Secondary to Branch Retinal Vein Occlusion Cardiovascular Diseases Embolism and Thrombosis Eye Diseases Macular Degeneration Macular Edema Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Retinal Degeneration Retinal Diseases Retinal Vein Occlusion Sensation Disorders Signs and Symptoms Thrombosis Vascular Diseases Venous Thrombosis Vision Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ranibizumab 0.5 mg

Drug

intravitreal injection of 0.05 ml

Sham Injection

Other

Sham intravitreal injection

Other names: Sham

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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

  2. Best Corrected Visual Acuity (BCVA) Change Over Time

    Time frame: 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

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

    Time frame: Baseline to 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

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

    Time frame: Baseline to 12 months

    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.

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

    Time frame: Month 1 to month 12

    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

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

    Time frame: month 3, 6 and 12

    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

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

    Time frame: Months 3, 6 and 12

    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

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

    Time frame: Months 3, 6 and 12

    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

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

    Time frame: Baseline, months 3, 6 and 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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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]

Acronym: Blossom

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Nov 5, 2013
Registry last updated
May 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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