Comparison of Ranibizumab Monotherapy and Ranibizumab Combination Therapies in Recurrent or Persistent Choroidal Neovascularization Secondary to Age-related Macular Degeneration
Age-Related Macular Degeneration, Neovascularization, Choroidal
About this trial
This is an interventional treatment trial for Age-Related Macular Degeneration
Eligibility Criteria
Inclusion Criteria:
- Patients 50 years of age or older.
- Patients with persistent or recurrence subfoveal CNV lesion secondary to AMD
- Patients who have a BCVA score better than 20/400 in the study eye using ETDRS.
- At least 6 initial intravitreal ranibizumab monotherapy
- The initial intravitreal ranibizumab treatment performed within the last 6 - 12 months.
Exclusion Criteria:
- Any prior initial intravitreal treatment other than intravitreal ranibizumab.
- History of glaucoma filtration surgery, corneal transplant surgery or extracapsular extraction of cataract with phacoemulsification within six months preceding Visit 1, or a history of post-operative complications within the last 12 months preceding Visit 1 in the study eye (uveitis, cyclitis etc.).
- History of uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with anti-glaucoma mediation).
- Aphakia or absence of the posterior capsule in the study eye.
- Presence of a retinal pigment epithelial tear involving the macula in the study eye.
- Any concurrent intraocular condition in the study eye (e.g., cataract or diabetic retinopathy) that, in the opinion of the investigator, could either require medical or surgical intervention during the three-month study period to prevent or treat visual loss that might result from that condition.
- Active intraocular inflammation (grade trace or above) in the study eye.
- Any active infection involving eyeball adnexa.
- Vitreous hemorrhage or history of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye.
- Other ocular conditions that require chronic concomitant therapy with systemic or topical ocular corticosteroids. Chronic concomitant therapy is defined as multiple doses taken daily for three or more consecutive days at any time within six months prior to screening or during the course of the study.
Sites / Locations
- Department of Ophthalmology, Medical University of Vienna
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Intravitreal dexamethasone and intravitreal ranibizumab
Intravitreal ranibizumab
Patients will receive intravitreal dexamethasone using a special drug delivery system and same day intravitreal ranibizumab. Study medications are initially given at the baseline visit. At each subsequent monthly follow-up visit, ranibizumab is administered if further visual deterioration or persistence of sub-/intraretinal fluid is detected in the examination. At month 3, 6, 9 and 12 further treatments with intravitreal dexamethasone in combination with intravitreal ranibizumab are given if leakage is detected in fluorescein or indocyanine green (FLA or ICG) angiography, in case of further vision decrease or persistence of sub-/intraretinal fluid in OCT.
Patients will receive intravitreal ranibizumab monotherapy (cohort 3). Study medications are initially given at the baseline visit. At each subsequent monthly follow-up visit, ranibizumab is administered if further visual deterioration or persistence of sub-/intraretinal fluid is detected in the examination