| July 31, 2007 |
| September 12, 2009 |
| August 2007 |
| December 2011 (final data collection date for primary outcome measure) |
| The proportion of subjects who maintain vision at Week 52, where a subject is classified as maintaining vision if the subject has lost fewer than 15 letters on the ETDRS chart compared to baseline (i.e. prevention of moderate vision loss) [ Time Frame: Week 52 ] [ Designated as safety issue: Yes ] |
| Primary measure will be visual acuity changes compared to baseline |
| Complete list of historical versions of study NCT00509795 on ClinicalTrials.gov Archive Site |
- Mean change from baseline in BCVA as measured by ETDRS letter score at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: Yes ]
- The proportion of subjects who gain at least 15 letters of vision at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
- Mean change from baseline in total NEI VFQ-25 score at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
- Mean change from baseline in CNV area at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: Yes ]
|
| Secondary measures will be angiographic and anatomical changes compared to baseline. |
| |
| Vascular Endothelial Growth Factor(VEGF)Trap-Eye:Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration(AMD) |
| A Randomized, Double Masked, Active Controlled Phase III Study of the Efficacy, Safety, and Tolerability of Repeated Doses of Intravitreal VEGF Trap in Subjects With Neovascular Age-Related Macular Degeneration |
This study is a phase III, double-masked, randomized, study of the efficacy and safety of VEGF Trap-Eye in patients with neovascular age-related macular degeneration. Approximately 1200 patients will be randomized in the US and Canada. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Macular Degeneration |
- Drug: VEGF Trap-Eye
- Drug: Ranibizumab
|
| |
| |
| |
| Active, not recruiting |
| 1200 |
| December 2011 |
| December 2011 (final data collection date for primary outcome measure) |
Key Inclusion Criteria:
- Signed Informed Consent.
- Men and women ≥ 50 years of age.
- Active primary or recurrent subfoveal CNV lesions secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye.
- ETDRS best-corrected visual acuity of: 20/40 to 20/320 (letter score of 73 to 25) in the study eye.
- Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures.
- Able to read, (or, if unable to read due to visual impairment, be read to verbatim by the person administering the informed consent or a family member. See Appendix J.4) understand and willing to sign the informed consent form.
Key Exclusion Criteria:
- Any prior ocular (in the study eye) or systemic treatment or surgery for neovascular AMD except dietary supplements or vitamins.
- Any prior or concomitant therapy with another investigational agent to treat neovascular AMD in the study eye, except dietary supplements or vitamins.
- Any prior treatment with anti-VEGF agents in the study eye.
- Total lesion size > 12 disc areas (30.5 mm2, including blood, scars and neovascularization) as assessed by FA in the study eye.
- Subretinal hemorrhage that is either 50% or more of the total lesion area, or if the blood is under the fovea and is 1 or more disc areas in size in the study eye. (If the blood is under the fovea, then the fovea must be surrounded 270 degrees by visible CNV.)
- Scar or fibrosis, making up > 50% of total lesion in the study eye.
- Scar, fibrosis, or atrophy involving the center of the fovea.
- Presence of retinal pigment epithelial tears or rips involving the macula in the study eye.
- History of any vitreous hemorrhage within 4 weeks prior to Visit 1 in the study eye.
- Presence of other causes of CNV in the study eye.
- History or clinical evidence of diabetic retinopathy, diabetic macular edema or any other vascular disease affecting the retina,other than AMD, in either eye.
- Prior vitrectomy in the study eye.
- History of retinal detachment or treatment or surgery for retinal detachment in the study eye.
- Any history of macular hole of stage 2 and above in the study eye.
- Any intraocular or periocular surgery within 3 months of Day 1 on the study eye, except lid surgery, which may not have taken place within 1 month of day 1, as long as its unlikely to interfere with the injection.
|
| Both |
| 50 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Canada |
| |
| NCT00509795 |
| Dr. Avner Ingerman, Regeneron Pharmaceuticals |
| VGFT-OD-0605 |
| Regeneron Pharmaceuticals |
| Bayer |
| Study Director: |
Avner Ingerman, MD |
Regeneron Pharmaceuticals |
|
|
| Regeneron Pharmaceuticals |
| September 2009 |