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

September 14, 2015 updated by: Norwegian University of Science and Technology

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

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.

Study Overview

Status

Terminated

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Trondheim, Norway, 7489
        • Department of neuroscience, NTNU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Observation
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Tor Elsaas, Prof. MD, Norwegian University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (ACTUAL)

September 1, 2015

Study Completion (ACTUAL)

September 1, 2015

Study Registration Dates

First Submitted

December 7, 2012

First Submitted That Met QC Criteria

December 10, 2012

First Posted (ESTIMATE)

December 11, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

September 15, 2015

Last Update Submitted That Met QC Criteria

September 14, 2015

Last Verified

September 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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