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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Norwegian University of Science and Technology
Sponsor:
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01746875
First received: December 7, 2012
Last updated: July 25, 2014
Last verified: July 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    BCVA on ETDRS will be compared from baseline to 6 months

  • Visual acuity from baseline to 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    BCVA on ETDRS will be compared from baseline to 12 months

  • Safety [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Development of CNV seen with OCT, fluorescein and indocyanine green imaging


Estimated Enrollment: 60
Study Start Date: February 2014
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2017 (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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01746875

Contacts
Contact: Dordi Austeng, MD dordi.austeng@ntnu.no

Locations
Norway
Department of Neuroscience, NTNU Recruiting
Trondheim, Norway, 7489
Principal Investigator: Dordi Austeng, MD         
Sub-Investigator: Arnt-Ole Tvenning, MD         
Sponsors and Collaborators
Norwegian University of Science and Technology
Investigators
Principal Investigator: Tor Elsaas, Prof. MD Norwegian University of Science and Technology
  More Information

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01746875     History of Changes
Other Study ID Numbers: 2012/1743
Study First Received: December 7, 2012
Last Updated: July 25, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics

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

Additional relevant MeSH terms:
Retinal Detachment
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Verteporfin
Photosensitizing Agents
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on October 19, 2014