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

Novartis

Status and phase: Completed; Phase 3

Conditions: Diabetic Macular Edema

Treatments: Procedure: Sham laser photocoagulation; Drug: Sham ranibizumab; Procedure: Laser photocoagulation; Drug: Ranibizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00989989

CRFB002D2303

Details and patient eligibility

About

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).

Enrollment: 396 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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396 participants in 3 patient groups

Adjunctive treatment

Experimental group

Description:

Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.

Treatment:

Drug: Ranibizumab

Procedure: Laser photocoagulation

Monotherapy treatment

Experimental group

Description:

Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.

Treatment:

Drug: Ranibizumab

Procedure: Sham laser photocoagulation

Laser control

Active Comparator group

Description:

Active laser treatment plus sham intravitreal injections.

Treatment:

Drug: Sham ranibizumab

Procedure: Laser photocoagulation