Clinical trial NCT00989989: Efficacy and Safety of Ranibizumab (Intravitreal Injections) in Patients With Visual Impairment Due to Diabetic Macular Edema
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetic Macular Edema
Keywords: DME
Diabetic
macula
edema
ranibizumab
REVEAL
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-10-06
Enrollment: 396
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: Average Change From Baseline of Best-Corrected Visual Acuity (BCVA) Over 12 Months (From Month 1 to Month 12 Compared to Baseline)
timeFrame: 12 months
Secondary outcomes:
measure: Change From Baseline on Central Retinal Subfield Thickness (CRST) at Month 12
timeFrame: 12 months
measure: Percent of Participants With Anatomical Changes in Intra-retinal Cysts at End of Study Compared to Baseline
timeFrame: Up to 12 months
measure: Percent of Participants With Anatomical Changes in Sub-retinal Fluid at End of Study Compared to Baseline
timeFrame: Up to 12 months
measure: Percent of Participants With Visual Acuity Above 73 Letters at Month 12
timeFrame: 12 months
measure: Percent of Participants Who Gained >= 10 Letters at Month 12 Compared to Baseline
timeFrame: 12 months
measure: Percent of Participants Who Lost >= 10 Letters at Month 12 Compared to Baseline
timeFrame: 12 months
measure: Percent of Participants Who Gained >= 15 Letters at Month 12 Compared to Baseline
timeFrame: 12 months
measure: Percent of Participants Who Lost >= 15 Letters at Month 12 Compared to Baseline
timeFrame: 12 months
measure: Best-Corrected Visual Acuity (BCVA) Mean Change From Baseline at Month 12
timeFrame: 12 months
measure: Patient Outcome Measure Euro Quality of Life Questionnaire (EQ-5D)
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Novartis Investigative Site
city: Changsha
country: China
facility: Novartis Investigative Site
city: Chengdu
country: China
facility: Novartis Investigative Site
city: Chongqing
country: China
facility: Novartis Investigative Site
city: Guangzhou
country: China
facility: Novartis Investigative Site
city: Hangzhou
country: China
facility: Novartis Investigative Site
city: Shanghai
country: China
facility: Novartis Investigational Site
city: Wenzhou
country: China
facility: Novartis Investigative Site
city: Xi'an
country: China
facility: Novartis Investigative Site
city: Hong Kong
country: Hong Kong
facility: Novartis Investigative Site
city: Chiba
country: Japan
facility: Novartis Investigative Site
city: Chiyoda-ku
country: Japan
facility: Novartis Investigative Site
city: Chuo-ku
country: Japan
facility: Novartis Investigative Site
city: Fukuoka
country: Japan
facility: Novartis Investigative Site
city: Fukushima
country: Japan
facility: Novartis Investigative Site
city: Hirakata
country: Japan
facility: Novartis Investigative Site
city: Kita-gun
country: Japan
facility: Novartis Investigative Site
city: Kobe
country: Japan
facility: Novartis Investigative Site
city: Kyoto
country: Japan
facility: Novartis Investigative Site
city: Mitaka
country: Japan
facility: Novartis Investigative Site
city: Nagoya
country: Japan
facility: Novartis Investigative Site
city: Osaka
country: Japan
facility: Novartis Investigative Site
city: Otsu
country: Japan
facility: Novartis Investigative Site
city: Shimotsuke
country: Japan
facility: Novartis Investigative Site
city: Shinjuku-ku
country: Japan
facility: Novartis Investigative Site
city: Suita
country: Japan
facility: Novartis Investigative Site
city: Toyko
country: Japan
facility: Novartis Investigative Site
city: Urayasu
country: Japan
facility: Novartis Investigative Site
city: Wakayama
country: Japan
facility: Novartis Investigative Site
city: Yamagata
country: Japan
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Kaohsiung
country: Taiwan
facility: Novartis Investigative Site
city: LinKou
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: