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

This study has been terminated.
(treatment effects not as desired)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01746875
First Posted: December 11, 2012
Last Update Posted: September 15, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Norwegian University of Science and Technology
  Purpose
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 Intervention
Macular Degeneration Retinal Detachment Drug: Aflibercept Drug: Verteporfin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Pigment Epithelium Detachment - a Prospective Clinical Study. PED-study.

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Visual acuity from baseline to 6 months [ Time Frame: 6 months ]
    BCVA on ETDRS will be compared from baseline to 6 months

  • Visual acuity from baseline to 12 months [ Time Frame: 12 months ]
    BCVA on ETDRS will be compared from baseline to 12 months

  • Safety [ Time Frame: 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 [ Time Frame: 24 months ]
    Change in OCT Central Retinal Thickness (CRT) and Volume of PED from baseline through 24 months

  • Development of choroidal neovascularisations (CNV) [ Time Frame: 24 months ]
    Development of CNV seen with OCT, fluorescein and indocyanine green imaging


Enrollment: 9
Study Start Date: February 2014
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01746875


Locations
Norway
Department of Neuroscience, NTNU
Trondheim, Norway, 7489
Sponsors and Collaborators
Norwegian University of Science and Technology
Investigators
Principal Investigator: Tor Elsaas, Prof. MD Norwegian University of Science and Technology
  More Information

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01746875     History of Changes
Other Study ID Numbers: 2012/1743
First Submitted: December 7, 2012
First Posted: December 11, 2012
Last Update Posted: September 15, 2015
Last Verified: September 2015

Keywords provided by Norwegian University of Science and Technology:
Angiogenesis inhibitors
Photochemotherapy
Vascular Endothelium Growth Factors
Aflibercept

Additional relevant MeSH terms:
Macular Degeneration
Dissociative Disorders
Retinal Detachment
Retinal Degeneration
Retinal Diseases
Eye Diseases
Mental Disorders
Verteporfin
Photosensitizing Agents
Dermatologic Agents