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Completed

NCT Number: NCT00989989

Efficacy and Safety of Ranibizumab (Intravitreal Injections) in Patients With Visual Impairment Due to Diabetic Macular Edema

This study was designed to confirm the efficacy and safety of ranibizumab (0.5 mg) as adjunctive therapy when added to laser photocoagulation and/or as monotherapy in Asian patients with visual impairment due to Diabetic Macular Edema (DME).

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Key information

Conditions

Diabetic Macular Edema Edema Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Beijing, 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 Type 1 or Type 2 diabetes mellitus according to American Diabetes Association (ADA) or World Health Organization (WHO) guidelines with HbA1c not more than 10.0% at screening (Visit 1). Patients should be on diet, exercise, and/or pharmacological treatment for diabetes.
  • Patients with visual impairment due to focal or diffuse Diabetic Macular Edema in at least one eye who are eligible for laser treatment in the opinion of the investigator. If both eyes are eligible, the one with the worse visual acuity, as assessed at Visit 1, will be selected for study treatment unless, based on medical reasons, the investigator deems the other eye the more appropriate candidate for study treatment.
  • The study eye must fulfill the following criteria at Visit 1:
  • Best-Corrected Visual Acuity (BCVA) score between 78 and 39 letters, inclusively, using Early Treatment of Diabetic Retinopathy (ETDRS) chart-like visual acuity testing charts at a testing distance of 4 meters (approximate Snellen equivalent of 20/32 to 20/160).
  • Decrease in vision is due to DME and not due to other causes, in the opinion of the investigator.
  • Medication for the management of diabetes must have been stable within 3 months prior to randomization and is expected to remain stable during the course of the study.

Exclusion criteria

  • Ocular concomitant conditions/ diseases:
  • Concomitant conditions in the study eye which could, in the opinion of the investigator, prevent the improvement of visual acuity on study treatment.
  • Active intraocular inflammation in either eye.
  • Any active infection in either eye.
  • History of uveitis in either eye.
  • Uncontrolled glaucoma in either eye.
  • Ocular treatments:
  • Panretinal laser photocoagulation in the study eye within 6 months prior to or during the study.
  • Focal/grid laser photocoagulation in the study eye within 3 months prior to study entry.
  • Systemic conditions or treatments:
  • History of stroke
  • Renal failure requiring dialysis or renal transplant or renal insufficiency with creatinine level > 2.0 mg/dL.
  • Untreated diabetes mellitus
  • Blood pressure systolic > 160 mmHg or diastolic > 100 mmHg
  • Compliance/ Administrative:
  • Pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

ranibizumab

Drug

Ranibizumab 0.5 mg intravitreal injection at day 1, month 1 and month 2. If stable vision not reached at month 3, one injection per month continued until stable vision was reached. Intravitreal injections re-initiated if needed.

Laser Photocoagulation

Procedure

Active laser treatment administered at day 1. Subsequent laser treatments administered if needed at intervals no shorter than 3 months from previous laser treatment.

Sham ranibizumab

Drug

Sham intravitreal injections to ranibizumab at day 1, month 1 and month 2. Intravitreal injections re-initiated if needed.

Sham laser photocoagulation

Procedure

Sham laser treatment administered at day 1.

Primary outcomes

  1. Average Change From Baseline of Best-Corrected Visual Acuity (BCVA) Over 12 Months (From Month 1 to Month 12 Compared to Baseline)

    Time frame: 12 months

    Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A positive average change from baseline of BCVA indicates improvement.

Secondary outcomes

  1. Change From Baseline on Central Retinal Subfield Thickness (CRST) at Month 12

    Time frame: 12 months

    Central Retinal Subfield Thickness (CRST) was measured using Optical Coherence Tomography (OCT) in micrometers. A negative change from baseline of CRST indicates improvement.

  2. Percent of Participants With Anatomical Changes in Intra-retinal Cysts at End of Study Compared to Baseline

    Time frame: Up to 12 months

    Presence or absence of intra-retinal cysts in any of the 6 sections of the study eye was measured using Optical Coherence Tomography (OCT). A complete resolution or decrease from baseline of intra-retinal cysts indicates improvement.

  3. Percent of Participants With Anatomical Changes in Sub-retinal Fluid at End of Study Compared to Baseline

    Time frame: Up to 12 months

    Presence or absence of sub-retinal fluid in any of the 6 sections of the study eye was measured using Optical Coherence Tomography (OCT). A complete resolution or decrease from baseline of sub-retinal fluid indicates improvement.

  4. Percent of Participants With Visual Acuity Above 73 Letters at Month 12

    Time frame: 12 months

    Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart at baseline and month 12 while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. BCVA above 73 letters at month 12 indicates a positive outcome.

  5. Percent of Participants Who Gained >= 10 Letters at Month 12 Compared to Baseline

    Time frame: 12 months

    Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A gain of 10 or more BCVA letters from baseline indicates improvement. A BCVA of 84 letters or more at Month 12 indicates improvement.

  6. Percent of Participants Who Lost >= 10 Letters at Month 12 Compared to Baseline

    Time frame: 12 months

    Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A loss of 10 or more BCVA letters from baseline indicates worsening.

  7. Percent of Participants Who Gained >= 15 Letters at Month 12 Compared to Baseline

    Time frame: 12 months

    Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A gain of 15 or more BCVA letters from baseline indicates improvement. A BCVA of 84 letters or more at Month 12 indicates improvement.

  8. Percent of Participants Who Lost >= 15 Letters at Month 12 Compared to Baseline

    Time frame: 12 months

    Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A loss of 15 or more BCVA letters from baseline indicates worsening.

  9. Best-Corrected Visual Acuity (BCVA) Mean Change From Baseline at Month 12

    Time frame: 12 months

    Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A positive change from baseline of BCVA indicates improvement.

  10. Patient Outcome Measure Euro Quality of Life Questionnaire (EQ-5D)

    Time frame: 12 months

    The Euro Quality of Life Questionnaire (EQ-5D) standardized instrument was utilized to measure health outcomes related to mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Participants self-rate their health on a visual, vertical analogue scale from 0 to 100 where the endpoints are labeled "Best imaginable health state" (100) and "worst imaginable health state" (0).

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A Randomized, Double-masked, Multicenter, Laser Controlled Phase III Study Assessing the Efficacy and Safety of Ranibizumab (Intravitreal Injections) as Adjunctive and Monotherapy in Patients With Visual Impairment Due to Diabetic Macular Edema

Acronym: REVEAL

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Oct 6, 2009
Registry last updated
Oct 18, 2012

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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