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Completed

NCT Number: NCT02259088

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

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

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Key information

Conditions

Diabetic Macular Edema Diabetes Mellitus Endocrine System Diseases Eye Diseases Glucose Metabolism Disorders Macular Degeneration Macular Edema Metabolic Diseases Nervous System Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Retinal Degeneration Retinal Diseases Sensation Disorders Signs and Symptoms Vision Disorders Visual Impairment

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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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Ranibizumab (RFB002)

Drug

Ranibizumab 0.5 mg/0.05 mL for intravitreal injection

Other names: Lucentis

LASER

Procedure

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

Sham injection

Drug

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

Sham laser

Procedure

Imitation of an active laser

Primary outcomes

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

    Time frame: Baseline, Monthly from Month 1 through 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. 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 outcomes

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

    Time frame: Baseline, Monthly from Month 1 through 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.

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

    Time frame: Baseline, Monthly from Month 1 through Month 12

    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.

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

    Time frame: Baseline, 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.

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

    Time frame: Baseline, 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.

  5. Percentage of Patients With BCVA ≥ 73 Letters at Month 12

    Time frame: 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.

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

    Time frame: Monthly from Month 3 through 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. 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.

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

    Time frame: Baseline, Month 6, Month 12

    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.

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

    Time frame: Baseline, Month 6, 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.

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

    Time frame: Baseline, Month 6, 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.

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

    Time frame: Baseline, Month 6, 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.

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

    Time frame: Baseline, Month 6, 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.

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

    Time frame: Baseline, Month 6, 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.

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

    Time frame: Baseline, Month 6, 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.

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

    Time frame: Baseline, Month 6, 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.

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

    Time frame: Baseline, Month 6, 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.

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

    Time frame: Baseline, Month 6, 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.

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

    Time frame: Baseline, Month 6, 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.

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

    Time frame: Baseline, Month 6, 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.

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

    Time frame: Baseline, Month 6, 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.

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

    Time frame: Monthly from Month 3 through Month 12

    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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Acronym: REFINE

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Oct 8, 2014
Registry last updated
Feb 1, 2019

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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