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Efficacy and Safety of Ranibizumab 0.5 mg Administered as Two Alternative Dosing Regimens in Chinese Patients With nAMD (Age Related Macular Degeneration) (DRAGON)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01775124
First received: January 22, 2013
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

The study will evaluate the efficacy and safety of two different dosing regimens of ranibizumab (either monthly injections or injections as-needed based on the stability of a patient's vision) in Chinese patients with wet AMD . This study is to provide long-term safety data in the treatment of Chinese patients with wet AMD.


Condition Intervention Phase
Neovascular Age-related Macular Degeneration
Drug: Ranibizumab
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 24-month, Randomized, Double-masked, Controlled, Multicenter Study Evaluating the Efficacy and Safety of Ranibizumab 0.5 mg Administered as Two Alternative Dosing Regimens in Chinese Patients With Neovascular AMD

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Average change in Visual Acuity (Letters) from Month 3 through Month 12 [ Time Frame: Month 3 through Month 12 ] [ Designated as safety issue: No ]
    Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like VA testing charts at a testing distance of 4 meters. This outcome measure describes the difference between the VA averaged across all visits from Month 4 through 12 and the Month 3 Level of Visual Acuity (Letters) of the Study Eye. The treatment regimen up to Month 3 is the same in both treatment groups.


Secondary Outcome Measures:
  • Change from Baseline in Visual Acuity (Letters) of the Study Eye over time [ Time Frame: Baseline to Month 24 ] [ Designated as safety issue: No ]
    Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes the change in visual acuity at each visit compared to baseline

  • Gain of equal or more than 5, 10, 15, or 30 letters in Visual Acuity of the Study Eye over time [ Time Frame: Baseline to Month 24 ] [ Designated as safety issue: No ]
    Visual acuity (VA) was at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes for each post-baseline month whether or not a patient improved by equal or more than 5, 10, 15,or 30 letters of VA as compared to baseline.

  • Loss of less than 15 Letters of Visual Acuity in the study eye over time [ Time Frame: Baseline to Month 24 ] [ Designated as safety issue: No ]
    Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes for each post-baseline month whether or not a patient lost less than 15 letters of VA as compared with baseline.

  • Visual Acuity of more of 73 letters or more [ Time Frame: Month 12 and 24 ] [ Designated as safety issue: No ]
    Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes for Month 12 and Month 24 whether a patient had a VA score of 73 or more letters

  • Average Visual Acuity change (Letters) from Month 3 to Month 4 through Month 24 [ Time Frame: Month 3 to Month 24 ] [ Designated as safety issue: No ]
    Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes the difference between the average level of VA over all monthly post-baseline assessments from Month 4 to Month 24 and the Month 3 Level of VA. The treatment regimen up to Month 3 is the same in both treatment groups.

  • Average Visual Acuity change (Letters) from baseline to Month 1 through Month 12 (24) , [ Time Frame: Baseline to Month 24 ] [ Designated as safety issue: No ]
    Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes the difference between VA averaged across all visits from Month 1 through Month 12 (24) and the baseline VA level

  • Change from Baseline in Central Sub-Field Thickness (CSFT) of the study eye over time [ Time Frame: Baseline to Month 24 ] [ Designated as safety issue: No ]
    Central Sub-Field Thickness (CSFT) was assessed by Optical Coherence Tomography (OCT) and analyzed by a Central Reading Center. This outcome measure describes the change in CSFT at each visit compared to baseline

  • Number of re-treatments and re-treatment patterns over time in patients receiving PRN dosing of ranibizumab 0.5 mg [ Time Frame: Month 4 to Month 12 (24) ] [ Designated as safety issue: No ]
    Date and reason for treatment with ranibizumab will be collected on the dosage administration page. This outcome measure describes the number of re-treatments with ranibizumab in patients with (PRN)as needed dosing, duration of active treatment phases and duration of treatment-free intervals.

  • Frequency and severity of ocular and non-ocular adverse events over time [ Time Frame: Screening to Month 24 ] [ Designated as safety issue: Yes ]
    Ocular and non-ocular adverse events will be collected through non-directive questioning at every visit during the entire duration of the study.


Enrollment: 333
Study Start Date: February 2013
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ranibizumab 0.5 mg monthly
Monthly intravitreal injections of ranibizumab 0.5 mg in the core treatment period and PRN intravitreal injections of the same dose guided by BCVA stabilization in the extension treatment period
Drug: Ranibizumab
Intravitreal injections of 0.5 mg Ranibizumab
Experimental: Ranibizumab 0.5 mg PRN
PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization in the 23 month treatment period
Drug: Ranibizumab
Intravitreal injections of 0.5 mg Ranibizumab

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Patients with visual impairment due to neovascular AMD
  • A qualifying vision score at study entry Exclusion criteria
  • Active infection or inflammation either eye at study entry
  • Uncontrolled glaucoma in either eye
  • Any disorder in the study eye which may affect vision
  • Use of any systemic anti-VEGF-drugs within 3 months prior to study entry
  • Previous treatment of the study eye for wet AMD
  • Any surgery in the study eye 3 months prior to or planned with 6 month after study entry Other protocol-defined inclusion/exclusion criteria may apply
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01775124

  Show 23 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01775124     History of Changes
Other Study ID Numbers: CRFB002A2413
Study First Received: January 22, 2013
Last Updated: June 5, 2014
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Eye Diseases
Retinal Degeneration
Retinal Diseases

ClinicalTrials.gov processed this record on November 25, 2014