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

Sponsor

Norwegian University of Science and Technology (Other)

Overall Status

Terminated

CT.gov ID

NCT01746875

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Macular Degeneration Retinal Detachment	Drug: Aflibercept Drug: Verteporfin	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

9 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Pigment Epithelium Detachment - a Prospective Clinical Study. PED-study.

Study Start Date :

Feb 1, 2014

Actual Primary Completion Date :

Sep 1, 2015

Actual Study Completion Date :

Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment 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.	Drug: Aflibercept 2.0 mg monthly x 3 doses, then as needed based on recurrence of activity on OCT. If no effect after the initial 3 doses; 2.0 mg monthly x 3 doses is repeated. Drug: Verteporfin given if aflibercept does not have any effect. Verteporfin photodynamic therapy is given in combination with aflibercept and triamcinolone. The treatment can be repeated after 3 month.
No Intervention: Observation

Arm

Intervention/Treatment

Experimental: Treatment

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.

Drug: Aflibercept

2.0 mg monthly x 3 doses, then as needed based on recurrence of activity on OCT. If no effect after the initial 3 doses; 2.0 mg monthly x 3 doses is repeated.

Drug: Verteporfin

given if aflibercept does not have any effect. Verteporfin photodynamic therapy is given in combination with aflibercept and triamcinolone. The treatment can be repeated after 3 month.

No Intervention: Observation

Outcome Measures

Primary Outcome Measures

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

Visual acuity from baseline to 6 months [6 months]
BCVA on ETDRS will be compared from baseline to 6 months
Visual acuity from baseline to 12 months [12 months]
BCVA on ETDRS will be compared from baseline to 12 months
Safety [24 months]
Incidence and severity of ocular and non-ocular adverse events will be evaluated through 24 months
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
Development of choroidal neovascularisations (CNV) [24 months]
Development of CNV seen with OCT, fluorescein and indocyanine green imaging

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.