Status:
COMPLETED
Comparison of Ranibizumab Monotherapy and Ranibizumab Combination Therapies in Recurrent or Persistent Choroidal Neovascularization Secondary to Age-related Macular Degeneration
Lead Sponsor:
Medical University of Vienna
Conditions:
Age-Related Macular Degeneration
Neovascularization, Choroidal
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
Age-related macular degeneration (AMD) is by far the most common disorder in the group of irreversible causes of visual disability. AMD leads to dysfunction and loss of photoreceptors in the central r...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01162746
Start Date
October 1 2011
End Date
December 1 2015
Last Update
May 25 2017
Active Locations (1)
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1
Department of Ophthalmology, Medical University of Vienna
Vienna, Austria, 1090