Time Course of Activity Signs at SD-OCT High Frequency Intravitreal Ranibizumab Treatment in CNV Due to AMD

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to detect persisting or early new activity of choroidal neovascularization (CNV) due to age related macular degeneration (AMD) during the first 12 months following the first ranibizumab dose at baseline as assessed by weekly high resolution optical coherence tomography (OCT). Detection of persisting or new signs of CNV activity at OCT triggers further ranibizumab treatments considering that any ranibizumab injections can maximally be applied as often as 2-weekly.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vista Klinik
• Treatments: Ranibizumab

Criteria

Inclusion Criteria:

• Male or female patients ≥ 50 years of age.

• Patients with active primary subfoveal CNV secondary to AMD, including those with predominantly classic, minimally classic or occult lesions with no classic component.

• Evidence that CNV extends under the geometric center of the foveal avascular zone.

• Total CNV area encompassed within the lesion must be ≥ 50% of total lesion area.

• The total lesion area ≤ 12 disc areas for minimally classic or occult with no classic component and ≤ 9 disc areas (5400µm) in greatest linear dimension with predominantly classic lesions.

• Patients who have a BCVA of 20/32 to 20/320 (letter score of 78 to 25 letters) in the study eye using ETDRS charts.

• Willing and able to give written informed consent according to legal requirements, and who have signed the consent form prior to initiation of any study procedure.

• Willing and able to comply with study procedures.

Exclusion Criteria:

• Subretinal hemorrhage in the study eye that involves the center of the fovea, if the size of the hemorrhage is either ≥ 50% of the total lesion area or ≥ 1 disc area in size.

• Structural damage to the center of the macula (beside CNV) in the study eye.

• Presence of a retinal pigment epithelial tear involving the macula in the study eye.

• Patients with angioid streaks or precursors of CNV in either eye due to other causes.

• Concurrent disease in the study eye that could compromise visual acuity or require medical or surgical intervention during the 12-month study period.

• Vitreous hemorrhage, history of rhegmatogenous retinal detachment or macular hole.

• Active intraocular inflammation (grade trace or above) in the study eye.

• Any active infection involving ocular adnexa.

• History of uncontrolled glaucoma in the study eye.

• Aphakia with absence of the posterior capsule in the study eye.

• Any prior treatment in the study eye with verteporfin, subfoveal focal laser photo-coagulation, vitrectomy, transpupillary thermotherapy, intravitreally applied drugs.

• History of submacular surgery or other surgical intervention for AMD in the study eye.

• Extracapsular extraction of cataract within 3 months preceding Baseline.

• Previous violation of posterior capsule in the study eye (unless YAG capsulotomy).

• History of Stroke.

• Pregnant or nursing (lactating) women.

• History of hypersensitivity or allergy to fluorescein.

• Inability to obtain OCT/photographs/fluorescein angiograms of sufficient quality.