A Study Testing if Medicine Can Make Pigment Epithelium Detachments Regress and Stabilize the Vision in Eyes

Not Applicable

Terminated

• Conditions: Macular Degeneration; Retinal Detachment
• Interventions: Drug: Aflibercept; Drug: Verteporfin

• Registration Number: NCT01746875
• Lead Sponsor: Norwegian University of Science and Technology

Brief Summary

The purpose of this study is to determine treatment effects in patients with retinal pigment epithelium detachment (PED) in relation to Age Related Maculopathy (AMD). Patients with newly diagnosed PED without choroidal neovascularisations (CNV), will be randomized to either treatment or observation. The treatment group will first be given injections with anti Vascular Endothelium Growth Factor (anti-VEGF). If the injections do not have any effect, Verteporfin Photodynamic Therapy (PDT) will be given. All patients will be followed for a period of 2 years. It is hypothesized that treatment stops the progression of the disease and stabilizes the vision in this subgroup of patients with AMD.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-12-07
• Study First Submitted QC: 2012-12-10
• Study First Posted: 2012-12-11
• Study Start: 2014-02
• Status Verified: 2015-09
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Last Update Submitted: 2015-09-14
• Last Update Posted: 2015-09-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• Ability to provide written informed consent and comply with study assessments for the full duration of the study
• Age > 50 years
• Pigment epithelium detachment in an eye not earlier treated with anti-VEGF or verteporfin PDT.
• ETDRS Best Corrected Visual acuity 20/32 - 20/400

Exclusion Criteria

• Prior treatment with verteporfin, or external-beam radiation therapy, or transpupillary thermotherapy, Previous subfoveal focal laser photocoagulation involving the foveal center, History of vitrectomy, submacular surgery, or other surgical intervention for AMD.
• CNV, Subfoveal fibrosis or atrophy in study eye.
• Concurrent eye disease in the study eye that could compromise visual acuity (e.g., diabetic retinopathy, advanced glaucoma) or require medical or surgical intervention during the study. Active intraocular inflammation in the study eye.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Verteporfin	aflibercept intravitreal injections, 2.0 mg monthly x 3 doses, then injections as needed based on recurrence of activity on OCT. If no effect of the treatment; aflibercept intravitreal injections, 2.0 mg x 3 doses is repeated, then injections as needed based on recurrence of activity on OCT. If no effect of the treatment; verteporfin photo dynamic therapy.
Treatment	Aflibercept	aflibercept intravitreal injections, 2.0 mg monthly x 3 doses, then injections as needed based on recurrence of activity on OCT. If no effect of the treatment; aflibercept intravitreal injections, 2.0 mg x 3 doses is repeated, then injections as needed based on recurrence of activity on OCT. If no effect of the treatment; verteporfin photo dynamic therapy.

Primary Outcome Measures

Name	Time	Method
Mean change in visual acuity from baseline to 24 months	24 months	Best corrected visual acuity (BCVA) on the Early Treatment for Diabetic Retinopathy Study (ETDRS) chart at 4 meters will be compared

Secondary Outcome Measures

Name	Time	Method
Visual acuity from baseline to 12 months	12 months	BCVA on ETDRS will be compared from baseline to 12 months
Visual acuity from baseline to 6 months	6 months	BCVA on ETDRS will be compared from baseline to 6 months
Safety	24 months	Incidence and severity of ocular and non-ocular adverse events will be evaluated through 24 months
Development of choroidal neovascularisations (CNV)	24 months	Development of CNV seen with OCT, fluorescein and indocyanine green imaging
Change in Optical Coherence Tomography (OCT) measurements from baseline through 24 months	24 months	Change in OCT Central Retinal Thickness (CRT) and Volume of PED from baseline through 24 months

Trial Locations

Locations (1)

Department of Neuroscience, NTNU; 🇳🇴 Trondheim, Norway