OPHTH-010915: Aflibercept in Recurrent or Persistent CNV
Study Details
Study Description
Brief Summary
Age-related macular degeneration (AMD) and diabetic retinopathy are among the most common disorders causing visual disability in elderly people. AMD leads to dysfunction and loss of photoreceptors in the central retina. Neovascular AMD (nAMD) affects visual function early in the disease process.
The purpose of the study is to evaluate the effect of switching from ranibizumab therapy to the current routine therapy using aflibercept in eyes with treatment naive, recurrent or persistent nAMD, treatment naive diabetic retinopathy and pretreated diabetic retinopathy.
20 patients with recurrent or persistent nAMD, previously treated with intravitreal ranibizumab for up to one year will be included in this trial. Patients will be examined in monthly intervals over 12 months follow-up.
Examinations carried out will include: Best-corrected visual acuity (BCVA) using ETDRS charts at 4m distance, Reading Performance (RP), Standard ophthalmic examinations (SOE incl. funduscopy and applanation tonometry), Optical coherence tomography (OCT), Autofluorescence fundus image (AF) & red-free autofluorescence fundus image (RF), Color fundus photography (CFP), Fluorescein angiography and indocyaningreen angiography (FLA/ICG), Microperimetry (MP), as well as Non-invasive OCT based optical angiography (AngioVue).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| AMD patients previously teated with Lucentis Adults ≥ 50 years; Patients who have been treated with ranibizumab due to wet age-related macular degeneration for up to one year; Patients who have a BCVA score better than 20/400 in the study eye using ETDRS; Willingness and ability to comply with regular visits; Signed informed consent form; The patient can take his medicine in the prescribed manner. The prescribed drugs do not constitute an exclusion criteria. |
Drug: Aflibercept
|
| treatment naive AMD patients Adults ≥ 50 years; Patients who have a BCVA score better than 20/400 in the study eye using ETDRS; |
Drug: Aflibercept
|
| DME patients previously teated with Lucentis Adults ≥ 50 years; Patients who have been treated with ranibizumab due to DME for up to one year; Patients who have a BCVA score better than 20/400 in the study eye using ETDRS; |
Drug: Aflibercept
|
| treatment naive DME patients Adults ≥ 50 years; Patients who have a BCVA score better than 20/400 in the study eye using ETDRS; |
Drug: Aflibercept
|
Outcome Measures
Primary Outcome Measures
- Percent change in Best-Corrected Visual Acuity (BCVA) [After one year compared to baseline]
- Anatomic changes in the macula as assessed with OCT (central retinal thickness, morphologic changes, fundus photos) [after one year compared to baseline]
Secondary Outcome Measures
- Number of retreatments [after one year]
Eligibility Criteria
Criteria
Inclusion Criteria:
Adults ≥ 50 years
-
Patients who have been treated with ranibizumab due to wet age-related macular degeneration for up to one year
-
BCVA >= 20/400 in the study eye using ETDRS
-
Willingness and ability to comply with regular visits
-
Signed informed consent
Exclusion Criteria:
-
Any surgical treatment of the eye within 3 months prior to baseline in the study eye
-
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 (excluding YAG-capsulotomy) in the study eye
-
Retinal pigment epithelial tear involving the macula in the study eye
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Medical University of Vienna | Vienna | Austria | 1090 |
Sponsors and Collaborators
- Medical University of Vienna
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- OPHTH-010915 (Ex-Oct)