Phase 4
Completed N=154
Study to Assess Best Corrected Visual Acuity (BCVA) in Patients With Neovascular Age-Related Macular Degeneration (AMD) Who Are Administered VEGF Trap-Eye (Intravitreal Aflibercept Injection)
Age - Related Macular Degeneration (AMD)
Source: ClinicalTrials.gov NCT01722045 ↗
Enrolled (actual)
154
Serious AEs
29.2%
Results posted
Dec 2017
Primary outcomePrimary: Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score From Baseline to Week 100 - Last Observation Carried Forward (LOCF) — 58.7; 4.5 letters correctly read
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This is a phase 4, open-label, single arm, multicenter, clinical study in patients with neovascular AMD designed to evaluate the efficacy and safety of Intravitreal Aflibercept Injection (IAI) administered over 2 years , and to provide clinical information from the first year in the trial evaluating the adverse effects, if any, on the corneal endothelium following administration of IAI.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score From Baseline to Week 100 - Last Observation Carried Forward (LOCF) |
58.7; 4.5 | — |
| SECONDARY Percentage of Participants Whose Optical Coherence Tomography (OCT) Status Was "Dry" at Week 52 and at Week 100 (LOCF) |
0.7; 99.3; 53.0; 47.0; 51.7; 48.3 | — |
| SECONDARY Percentage of Participants Who Gained ≥15 ETDRS Letters Compared With Baseline at Week 52 and Week 100 (LOCF) |
25.8; 22.5 | — |
| SECONDARY Change From Baseline in Best Corrected Visual Acuity Score Through Week 52 (LOCF) |
60.1; 5.9 | — |
| SECONDARY Percentage of Participants Who Gained ≥0, ≥5, ≥10, or ≥30 Letters From Baseline in BCVA Through Week 100 (LOCF) |
70.9; 57.6; 40.4; 4.6 | — |
| SECONDARY Percentage of Patients Who Lost >0, ≥5, ≥10, or ≥15 Letters From Baseline in BCVA Through Week 100 (LOCF) |
29.1; 23.2; 16.6; 13.2 | — |
Eligibility Criteria
Inclusion criteria include but are not limited to:
- Men or women great than or equal to 50 years of age with unilateral neovascular AMD
- BCVA ETDRS letter score of 73 to 24 (20/40 to 20/320) in the study eye
- Active primary subfoveal choroidal neovascularization (CNV) lesions secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye
- The CNV area must be at least 50% of total lesion size
- Willing and able to comply with clinic visits and study-related procedures
- Provide signed informed consent
- Provide signed Health Insurance Portability and Accountability Act (HIPAA) authorization
Exclusion criteria include but are not limited to:
- Neovascular AMD in the fellow eye
- Corneal endothelial measures as judged by an independent reading center
- Any prior use of intraocular anti-VEGF treatment for neovascular AMD in either eye
- Structural damage to the center of the macula in the study eye that is likely to preclude improvement in BCVA following the resolution of macular edema
- History of cataract surgery, or other intraocular surgery in either eye, within 1 year of screening
- History of cataract surgery, or other intraocular surgery in either eye, within 1 year of screening, or yttrium aluminum garnet (YAG) Capsulotomy within 3 months of screening
- Contact lens wear in either eye within 6 months of screening
- History of angle closure glaucoma in either eye
- Intraocular laser therapy including selective laser trabeculoplasty (SLT), YAG, prophylactic peripheral iridotomy (PI) in either eye within 1 year of screening, or YAG Capsulotomy within 3 months of screening
- History of cataract surgery requiring an anterior chamber intraocular lens implant at any time in either eye
- Any prior ocular trauma (blunt or penetrating) in either eye
- Embedded corneal foreign body in either eye
- Evidence of infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye
- Ocular media of insufficient quality to obtain fundus and OCT images in the study eye
- Any prior ocular inflammation/infection in either eye within 3 months of the screening visit
- Any prior use of amantadine
- Significant pre-retinal fibrosis involving the macula in the study eye (where, in the opinion of the investigator, the pre-retinal fibrosis is causing distortion or traction on the central macular region which may be limiting vision, or inducing retinal edema/thickening, beyond that due to underlying CNV)
- Intraocular pressure (IOP) greater than or equal to 30 mm Hg in the study eye at screening
- Uncontrolled diabetes mellitus (DM) (HbA1c ≥8)
- Current treatment with systemic anti-VEGF therapeutics at screening
- Known serious allergy to the fluorescein sodium for injection in angiography
- Participation in an investigational study within 30 days prior to the screening visit that involved treatment with any drug (excluding vitamins and minerals) or device.
- Positive serum hCG pregnancy test at the screening visit
Data sourced from ClinicalTrials.gov (NCT01722045). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.