Age Related Macular Degeneration
Conditions
Brief summary
This study is designed to compare the effect of combined intravitreal Bevacizumab and Propranolol injection versus Bevacizumab monotherapy in patients with Age Related Macular Degeneration. Methods: In this study patients with Age Related Macular Degeneration who are naïve or had history of previous treatment are included. The eligible patients in randomized in two groups Bevacizumab and Bavacizumab + propranolol and in injected intravitreally for 3 times monthly. In Bevacizumab+propranolol group patients receive two injections at each session Bavacizumab and propranolol. In Bevacizumab group patients receive only Bevacizumab. The patients are followed for 6 months and central macular thickness and visual acuity is measured at baseline and monthly for 6 month. Baseline ancillary exams include Fluorescein Angiography and OCT-Angiography which is performed at the final exam as well. Patients needing any therapeutic intervention is addressed during the 6 month follow up period.
Interventions
DRUGCombined Intravitreal bevacizumab and propranolol
these patients receive two injections at each session Bavacizumab and propranolol
these patients receive only Bevacizumab
Sponsors
Shahid Beheshti University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients with Wet AMD and Vision less than 20/40
Exclusion criteria
* History of cardiac ,renal, respiratory diseases (due to beta blocker toxicity), * Associated with other Macular abnormalities such as Diabetic Retinopathy, Macular traction * History of ocular inflammation * Subretinal fibrosis * History of Cataract surgey less than 6 months * History of Glaucoma Surgery ,Vitreoretinal surgery * Media opacity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Macular Thickness | 1 month | Spectral Domain Optical Coherence Tomography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual acuity | 1 month | Early Treatment Diabetic Retinopathy Study |
Countries
Iran
Contacts
Primary ContactRamin Noorinia, MD
Outcome results
None listed