Phase 4
Completed N=46
Study for Recalcitrant Age Related Macular Degeneration
Source: ClinicalTrials.gov NCT01543568 ↗Enrolled (actual)
46
Serious AEs
20.0%
Results posted
Jan 2017
Primary outcomePrimary: The Number of Patients With no Fluid on OCT — 10 participants
◆ Published Evidence
Established
86citations · ~7 / year
Aflibercept treatment for patients with exudative age-related macular degeneration who were incomplete responders to multiple ranibizumab injections (TURF trial).
Summary
50 Patients with recalcitrant exudative age-related macular degeneration with a history of retinal or subretinal fluid after multiple intravitreal injections with ranibizumab 0.5mg and subsequently treated with ranibizumab 2.0mg, who are incomplete responders to 2.0mg of ranibizumab.
Linked Publications
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Aflibercept treatment for patients with exudative age-related macular degeneration who were incomplete responders to multiple ranibizumab injections (TURF trial).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Patients With no Fluid on OCT |
10 | — |
| SECONDARY Mean Change in OCT Central Foveal Thickness |
-27.3 | — |
| SECONDARY Average Time to Resolution of Intraretinal Cysts and Sub Retinal Fluid on OCT |
4 | — |
| SECONDARY The Percentage of Patients Who Lose > 15 Letters Visual Acuity |
— | — |
| SECONDARY Mean Change in Visual Acuity (BCVA) |
0.2 | — |
| SECONDARY Quantitative Change in Area (μ) From Baseline in Choroidal Neovascular Lesion Characteristics/Size as Measured by FA/Fundus Photos |
— | — |
| SECONDARY Mean Number of 0.2 mg Aflibercept Injections Administered |
5.6 | — |
Eligibility Criteria
Inclusion Criteria
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age > 50 years
- Choroidal neovascularization secondary to AMD
- History of treatment with 0.5mg ranibizumab followed by 2.0mg ranibizumab for AMD
- Best corrected visual acuity in the study eye between 20/20 to 20/400 using an ETDRS chart
Exclusion Criteria
- Pregnancy (positive pregnancy test) or lactation
- Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
- Participation in another simultaneous medical investigation or trial
- Prior treatment with anti-VEGF therapy in the study eye within 28 days of baseline
- Prior treatment with PDT within the past 3 months or more than 4 prior PDT treatments.
- Presence of significant subfoveal fibrosis or atrophy.
- Prior treatment with intravitreal aflibercept injection
- Prior treatment with triamcinolone in the study eye within 6 months of BSL.
- Prior treatment with dexamethasone in the study eye within 30 days prior to BSL
- Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding Baseline
- History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye
- Active intraocular inflammation (grade trace or above) in the study eye
- Current vitreous hemorrhage in the study eye
- History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye
- Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
- Uncontrolled glaucoma in the study eye (defined as IOP ≥ 30 mmHg despite treatment with anti-glaucoma medication)
- History of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 3 months of study enrollment.
- History of allergy to fluorescein, ICG or iodine, not amenable to treatment
- History of retinal pigment epithelial tear or rip
Data sourced from ClinicalTrials.gov (NCT01543568) and the linked publication. 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.