VEGF Trap-Eye: Investigation of Efficacy and Safety in Chinese Subjects With Wet AMD (Age-Related Macular Degeneration)
This study is currently recruiting participants.
Verified May 2013 by Bayer
Sponsor:
Bayer
Collaborator:
Regeneron Pharmaceuticals
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01482910
First received: November 29, 2011
Last updated: May 3, 2013
Last verified: May 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This study will assess the efficacy and safety of intravitreally (IVT), i.e. directly into the eyeball administered VEGF Trap-Eye compared with photodynamic therapy (PDT) on visual function in Chinese subjects with age-related neovascular or "wet" age-related macular degeneration.
Subjects will be randomized in a 3:1 ratio to either receive VEGF Trap-Eye or PDT. Both treatment groups will receive the other treatment as a sham procedure.
| Condition | Intervention | Phase |
|---|---|---|
|
Macular Degeneration |
Biological: VEGF Trap-Eye (BAY86-5321) Drug: Visudyne |
Phase 3 |
| 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 Randomized, Double-masked, Photodynamic Therapy-controlled Phase-3 Study of the Efficacy, Safety, and Tolerability of Intravitreal VEGF Trap-Eye in Chinese Subjects With Neovascular Age-Related Macular Degeneration |
Resource links provided by NLM:
Genetics Home Reference related topics:
age-related macular degeneration
tumor necrosis factor receptor-associated periodic syndrome
X-linked juvenile retinoschisis
MedlinePlus related topics:
Macular Degeneration
U.S. FDA Resources
Further study details as provided by Bayer:
Primary Outcome Measures:
- Change in BCVA (best corrected visual acuity) [ Time Frame: From baseline to week 28 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Proportion of subjects who lose fewer than 15 letters compared to Baseline [ Time Frame: At week 28 ] [ Designated as safety issue: No ]
- Adverse Event Collection [ Time Frame: From baseline to week 28 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 300 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 |
Biological: VEGF Trap-Eye (BAY86-5321)
Subjects in the VEGF Trap-Eye group will receive intravitreal injections every 8 weeks following a loading phase with injections given every 4 weeks for an overall treatment period of 48 weeks. Additionally, sham PDT treatments will be administered as needed.
|
| Active Comparator: Arm 2 |
Drug: Visudyne
Subjects in the PDT group (Visudyne group) will receive Visudyne as needed. Additionally, sham IVT injections will be administered until week 28. Thereafter, subjects in the PDT group will receive active (= no sham) VEGF Trap-Eye treatment until week 48.
|
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Signed and dated informed consent form
- Men and women ≥ 50 years of age.
- Active predominantly classic subfoveal choroidal neovascularization (CNV) lesions secondary to wAMD (wet Age-Related Macular Degeneration)
- BCVA (best corrected visual acuity) of 20/40 to 20/320 in the study eye
Exclusion Criteria:
- Only one functional eye
- Presence of CNV with an origin other than wAMD
- Any prior ocular or systemic treatment or surgery for wAMD, except dietary supplements or vitamins
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01482910
Contacts
| Contact: Bayer Clinical Trials Contact | clinical-trials-contact@bayerhealthcare.com | |
| Contact: For trial location information: (Phone Menu Options '3' or '4') | (+)1-888-84 22937 |
Locations
| China, Guangdong | |
| Recruiting | |
| Guangzhou, Guangdong, China, 510060 | |
| China, Hunan | |
| Recruiting | |
| Changsha, Hunan, China, 410011 | |
| China, Shaanxi | |
| Recruiting | |
| Xi'an, Shaanxi, China, 710032 | |
| China, Shandong | |
| Recruiting | |
| Qingdao, Shandong, China | |
| China, Sichuan | |
| Recruiting | |
| Chengdu, Sichuan, China, 610041 | |
| China, Zhejiang | |
| Recruiting | |
| Hangzhou, Zhejiang, China, 310009 | |
| Terminated | |
| Hangzhou, Zhejiang, China, 310003 | |
| Recruiting | |
| Wenzhou, Zhejiang, China | |
| China | |
| Recruiting | |
| Beijing, China, 100083 | |
| Recruiting | |
| Beijing, China, 2000080 | |
| Recruiting | |
| Beijing, China, 100044 | |
| Recruiting | |
| Beijing, China, 100730 | |
| Recruiting | |
| Shanghai, China | |
| Recruiting | |
| Tianjin, China, 300384 | |
Sponsors and Collaborators
Bayer
Regeneron Pharmaceuticals
Investigators
| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Therapeutic Area Head, Bayer Healthcare AG |
| ClinicalTrials.gov Identifier: | NCT01482910 History of Changes |
| Other Study ID Numbers: | 13406 |
| Study First Received: | November 29, 2011 |
| Last Updated: | May 3, 2013 |
| Health Authority: | China: Food and Drug Administration |
Additional relevant MeSH terms:
|
Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Verteporfin Photosensitizing Agents |
Radiation-Sensitizing Agents Physiological Effects of Drugs Pharmacologic Actions Dermatologic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013