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

NCT01775124 | Completed Phase 4 Results

• 1 other identifier: CRFB002A2413
• Study Type: interventional
• Target: 332
• Locations: 1 country
• Sites: 23

Brief Summary

The study evaluated 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 age-related macular degeneration (AMD) . This study was to provide long-term safety data in the treatment of Chinese patients with wet AMD.

Conditions

Neovascular Age-related Macular Degeneration

Keywords

Macular degeneration,; age-related macular degeneration (ARMD),; vision loss,; macula damage,; retina damage,; dry macular degeneration,; wet macular degeneration,; AMD

Outcome Measures

Primary Outcomes (1)

• Average Change in Visual Acuity (Letters) From Month 3 to Month 4 Through Month 12

  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.

  Month 3 to month 4 through Month 12

Secondary Outcomes (11)

• Average Visual Acuity Change (Letters) From Month 3 to Month 4 Through Month 24

  Month 3 to month 4 through Month 24

• Average Visual Acuity Change From Baseline to Month 1 Through Month 12 and Month 1 Through Month 24

  Baseline to Month 24

• Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time

  Baseline to 24 months

• Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24

  Baseline to Month 24

• Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time

  Baseline to Month 24

Study Arms (2)

Ranibizumab 0.5 mg monthly

EXPERIMENTAL

Monthly intravitreal injections of ranibizumab 0.5 mg in the core treatment period and PRN intravitreal injections of the same dose guided by best-corrected visual acuity (BCVA) stabilization in the extension treatment period

Drug: Ranibizumab

Ranibizumab 0.5 mg pro re nata (PRN)

EXPERIMENTAL

PRN intravitreal injections of ranibizumab 0.5 mg guided by best-corrected visual acuity (BCVA) stabilization in the 23 month treatment period

Drug: Ranibizumab

Interventions

Ranibizumab DRUG

Intravitreal injections of 0.5 mg Ranibizumab

Ranibizumab 0.5 mg monthly; Ranibizumab 0.5 mg pro re nata (PRN)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with visual impairment due to neovascular AMD

You may not qualify if:

• 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-vascular endothelial growth factor (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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (23)

Novartis Investigative Site

Beijing, Beijing Municipality, 100191, China

Location

Novartis Investigative Site

Beijing, Beijing Municipality, 100730, China

Location

Novartis Investigative Site

Chongqing, Chongqing Municipality, 400042, China

Location

Novartis Investigative Site

Lanzhou, Gansu, 730030, China

Location

Novartis Investigative Site

Harbin, Heilongjiang, 150001, China

Location

Novartis Investigative Site

Wuhan, Hubei, 430060, China

Location

Novartis Investigative Site

Wuhan, Hubei, 430070, China

Location

Novartis Investigative Site

Changsha, Hunan, 410011, China

Location

Novartis Investigative Site

Nanjing, Jiangsu, 210029, China

Location

Novartis Investigative Site

Nanchang, Jiangxi, 330006, China

Location

Novartis Investigative Site

Shenyang, Liaoning, 110011, China

Location

Novartis Investigative Site

Qingdao, Shandong, 2666000, China

Location

Novartis Investigative Site

Taiyuan, Shanxi, 030002, China

Location

Novartis Investigative Site

Chengdu, Sichuan, 610041, China

Location

Novartis Investigative Site

Tianjin, Tianjin Municipality, 300020, China

Location

Novartis Investigative Site

Tianjin, Tianjin Municipality, 300070, China

Location

Novartis Investigative Site

Wenzhou, Zhejiang, 325027, China

Location

Novartis Investigative Site

Beijing, 100044, China

Location

Novartis Investigative Site

Beijing, 100176, China

Location

Novartis Investigative Site

Chongqing, 400038, China

Location

Novartis Investigative Site

Shanghai, 200031, China

Location

Novartis Investigative Site

Shanghai, 200080, China

Location

Novartis Investigative Site

Shanghai, 200092, China

Location

MeSH Terms

Conditions

Macular Degeneration; Vision Disorders; Geographic Atrophy; Wet Macular Degeneration

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Study Director
• Organization: Novartis

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2013
• First Posted: January 24, 2013
• Study Start: February 22, 2013
• Primary Completion: November 23, 2015
• Study Completion: November 23, 2015
• Last Updated: September 4, 2019
• Results First Posted: February 12, 2018

Record last verified: 2019-08

Locations

CN (23)