Short-term Clinical Effects of Intravitreal Aflibercept Injection 2.0mg as a Predictor of Long-term Results
Status: | Active, not recruiting |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 50 - Any |
Updated: | 10/29/2017 |
Start Date: | October 2012 |
End Date: | December 2017 |
This is an open label study to evaluate 2.0 mg intravitreal aflibercept injection
administered in subject who have active choroidal neovascularization due to Age Related
Macular Degeneration (AMD).
administered in subject who have active choroidal neovascularization due to Age Related
Macular Degeneration (AMD).
Twenty (20) consented participant who meet the inclusion criteria will be enrolled to be
followed for 48 weeks. All subjects will receive 2.0 mg intravitreal aflibercept injections
with three initial monthly doses, and mandatory doses at Weeks 16, 24, 32, and 40. Dosing at
monthly intervals is allowed if needed in the opinion of the investigator based on presence
of fluid on Optical Coherence Tomography (OCT) and/or a decrease in visual acuity of greater
than or equal to 5 letters from the best previous visit. Only one eye will be enrolled in the
study.
followed for 48 weeks. All subjects will receive 2.0 mg intravitreal aflibercept injections
with three initial monthly doses, and mandatory doses at Weeks 16, 24, 32, and 40. Dosing at
monthly intervals is allowed if needed in the opinion of the investigator based on presence
of fluid on Optical Coherence Tomography (OCT) and/or a decrease in visual acuity of greater
than or equal to 5 letters from the best previous visit. Only one eye will be enrolled in the
study.
Inclusion Criteria:
Ability to provide written informed consent and comply with study assessments for the full
duration of the study.
Age 50 years and above.
Choroidal neovascularization secondary to AMD with central retinal thickness greater than
or equal to 300um.
Best corrected visual acuity in the study eye between 20/40 and 20/400 using an ETDRS chart
-
Exclusion Criteria:
Pregnancy (positive urine 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 a study or an investigational drug or device within the past 30 days prior
to enrolling in the study.
Presence of significant subfoveal fibrosis or atrophy.
Previously treated subjects:
Prior treatment with anti-VEGF therapy in the study eye within 28 days of baseline More
than six (6) prior treatments with anti-VEGF therapy in the study eye within 1 year.
Prior treatment with PDT within the past 3 months or more than 2 prior PDT treatments.
Prior treatment with intravitreal aflibercept injection Prior treatment with triamcinolone
in the study eye within 6 months of baseline.
Prior treatment with dexamethasone in the study eye within 30 days prior to baseline.
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 greater than or equal to 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.
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