Phase 4
N=46
Study for Recalcitrant Age Related Macular Degeneration
Age Related Macular Degeneration
Bottom Line
View on ClinicalTrials.gov: NCT01543568 ↗Enrolled (actual)
46
Serious AEs
20.0%
Results posted
Jan 2017
Primary outcome: Primary: The Number of Patients With no Fluid on OCT — 10 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- aflibercept 2.0 mg (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- David M. Brown, M.D.
- Primary completion
- Oct 2014
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 | — |
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.
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). 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.