A Pilot Study to Evaluate the Role of High-dose Ranibizumab (2.0mg) in the Management of AMD in Patients With Persistent/Recurrent Macular Fluid Less Than 30 Days Following Treatment With Intravitreal Anti-VEGF Therapy (the LAST Study)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Vitreous -Retina- Macula Consultants of New York
With
Genentech, Inc.
Age
50–any
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Ability to provide written informed consent and comply with study assessments for the full duration of the study
Age \> 50 years
Subfoveal neovascularization secondary to AMD
Best corrected visual acuity in the study eye between 20/30 to 20/400 using an ETDRS chart
Documentation of the presence of subretinal fluid and/or cystoid macular edema on SD-OCT less than 30 days following at least six months of anti-VEGF therapy
Presence of fibrosis, hemorrhage, or other hypofluorescent lesions should not obscure greater than 50% of the CNV lesion
You may not be if
Subjects who meet any of the following criteria will be excluded from this study:
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 30 days of BSL
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
Past treatment with PDT or thermal laser in the study eye
Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding BSL
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, not amenable to treatment
