NCT00989989

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).

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
396

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2009

Geographic Reach
6 countries

35 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 2, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 6, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

October 18, 2012

Completed
Last Updated

October 18, 2012

Status Verified

September 1, 2012

Enrollment Period

1.9 years

First QC Date

October 2, 2009

Results QC Date

July 26, 2012

Last Update Submit

September 18, 2012

Conditions

Diabetic Macular Edema

Keywords

DMEDiabeticmaculaedemaranibizumabREVEAL

Outcome Measures

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)

    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.

    12 months

Secondary Outcomes (10)

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

    12 months

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

    Up to 12 months

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

    Up to 12 months

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

    12 months

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

    12 months

  • +5 more secondary outcomes

Study Arms (3)

Adjunctive treatment

EXPERIMENTAL

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

Drug: RanibizumabProcedure: Laser photocoagulation

Monotherapy treatment

EXPERIMENTAL

Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.

Drug: RanibizumabProcedure: Sham laser photocoagulation

Laser control

ACTIVE COMPARATOR

Active laser treatment plus sham intravitreal injections.

Procedure: Laser photocoagulationDrug: Sham ranibizumab

Interventions

RanibizumabDRUG

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.

Adjunctive treatmentMonotherapy treatment
Laser photocoagulationPROCEDURE

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

Adjunctive treatmentLaser control
Sham ranibizumabDRUG

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

Laser control
Sham laser photocoagulationPROCEDURE

Sham laser treatment administered at day 1.

Monotherapy treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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:
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (35)

Novartis Investigative Site

Beijing, China

Location

Novartis Investigative Site

Changsha, China

Location

Novartis Investigative Site

Chengdu, China

Location

Novartis Investigative Site

Chongqing, China

Location

Novartis Investigative Site

Guangzhou, China

Location

Novartis Investigative Site

Hangzhou, China

Location

Novartis Investigational Site

Shanghai, China

Location

Novartis Investigative Site

Wenzhou, China

Location

Novartis Investigative Site

Xi'an, China

Location

Novartis Investigative Site

Hong Kong, Hong Kong

Location

Novartis Investigative Site

Chiba, Japan

Location

Novartis Investigative Site

Chiyoda-ku, Japan

Location

Novartis Investigative Site

Chūōku, Japan

Location

Novartis Investigative Site

Fukuoka, Japan

Location

Novartis Investigative Site

Fukushima, Japan

Location

Novartis Investigative Site

Hirakata, Japan

Location

Novartis Investigative Site

Kita-gun, Japan

Location

Novartis Investigative Site

Kobe, Japan

Location

Novartis Investigative Site

Kyoto, Japan

Location

Novartis Investigative Site

Mitaka, Japan

Location

Novartis Investigative Site

Nagoya, Japan

Location

Novartis Investigative Site

Osaka, Japan

Location

Novartis Investigative Site

Ōtsu, Japan

Location

Novartis Investigative Site

Shimotsuke, Japan

Location

Novartis Investigative Site

Shinjuku-ku, Japan

Location

Novartis Investigative Site

Suita, Japan

Location

Novartis Investigative Site

Toyko, Japan

Location

Novartis Investigative Site

Urayasu, Japan

Location

Novartis Investigative Site

Wakayama, Japan

Location

Novartis Investigative Site

Yamagata, Japan

Location

Novartis Investigative Site

Singapore, Singapore

Location

Novartis Investigative Site

Seoul, South Korea

Location

Novartis Investigative Site

Kaohsiung City, Taiwan

Location

Novartis Investigative Site

Linkou District, Taiwan

Location

Novartis Investigative Site

Taipei, Taiwan

Location

MeSH Terms

Conditions

Edema

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
41 61 324 1111

Study Officials

  • Novartis Pharmaceuticals

    Novartis

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2009

First Posted

October 6, 2009

Study Start

September 1, 2009

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

October 18, 2012

Results First Posted

October 18, 2012

Record last verified: 2012-09

Locations

TW(3)SG(1)CN(9)HK(1)JP(20)KR(1)