Intravitreal Macugen for Ischaemic Diabetic Macular Oedema (MIDME)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University of Oxford.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT01175070
First received: August 2, 2010
Last updated: June 20, 2012
Last verified: June 2012
  Purpose

Diabetic macular oedema (DME) is the leading cause of blindness in the UK's working population. It affects the macula, which lies at the centre of the retina, at the back of the eye. Damage to the macula can occur either because the blood supply is reduced (ischaemic DME), or because the blood vessels are leaking excessively (exudative DME).

A chemical called vascular endothelial growth factor (VEGF) may underlie some of the abnormalities seen in DME. Studies have shown that VEGF encourages leakage of fluid from blood vessels and increases the stickiness of white blood cells. When white blood cells are sticky they can attach to blood vessel walls. This may cause small blood vessels to block, and lead to ischaemia.

Laser treatment often helps to stabilise exudative DME, but there is currently no recognised treatment for ischaemic DME. Macugen (pegaptanib), a drug that inactivates VEGF, has been tried and found to be of benefit in treating exudative DME. Since VEGF promotes ischaemia, it is possible that Macugen will also prove to be beneficial for ischaemic DME. This has not been tested before.

A healthy macula is essential for good vision. The innermost area of the macula, the foveal avascular zone (FAZ), is the most important part. The FAZ is enlarged when it is ischaemic. This is a pilot study to assess whether Macugen can reduce the size of the FAZ in ischaemic DME. The investigators will also assess whether it can reduce retinal thickness and improve vision in ischaemic DME. Thirty patients will be involved in the study for thirty weeks each. They will have their eyes examined and receive an injection of Macugen into the eye every 6 weeks. The study is taking place in the Oxford Eye Hospital and is being funded by Pfizer, the company that makes Macugen.


Condition Intervention Phase
Diabetic Macular Oedema
Drug: Intravitreal injection of pegaptanib sodium
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase IV OpenLabelled Prospective Pilot Study of Intravitreal Macugen (Pegaptanib) for Ischaemic Diabetic Macular Oedema (MIDME Study)

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Change in size of FAZ at 30 weeks [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in central foveal thickness and best corrected visual acuity at 30 weeks. [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: January 2011
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pegaptanib
Participants receiving 6-weekly treatment with pegaptanib sodium (Macugen [TM]) for ischaemic diabetic macular oedema over a 30 week period.
Drug: Intravitreal injection of pegaptanib sodium
Eligible participants with ischaemic diabetic macular oedema will receive an intravitreal injection of pegaptanib sodium (Macugen [TM]) 0.3mg every 6 weeks over a 30 week period.
Other Name: Macugen 0.3mg

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant is willing and able to give informed consent for participation in the study.
  • Male or Female, aged 18 years or above.
  • DME
  • BCVA 20/32 to 20/320 inclusive
  • Central OCT thickness > 300 microns
  • Enlargement of FAZ (ischaemia or capillary drop out of >30% on FFA)
  • Female participants of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter
  • Able (in the Investigator's opinion) and willing to comply with all study requirements e.g. attending for tests and treatment every 6 weeks.
  • Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.

Exclusion Criteria:

  • Any co-existing ocular disease (with the exception of cataract)
  • Female participants who are pregnant, lactating or planning pregnancy during the course of the study
  • Any significant disease or disorder, e.g. recent stroke or myocardial infarction, which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study
  • Significant renal impairment, i.e. creatinine clearance < 20mL/min
  • Participants who have participated in another research study involving an investigational product in the past 12 weeks
  • Laser within 3 months
  • Intraocular surgery within 6 months
  • Known allergy to pegaptanib (Macugen [TM])
  • Known allergy to fluorescein
  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: NCT01175070

Locations
United Kingdom
Oxford Eye Hospital
Oxford, Oxfordshire, United Kingdom, OX3 9DU
Sponsors and Collaborators
University of Oxford
Pfizer
Investigators
Principal Investigator: Victor Chong, MPhil, MD, FRCSEd, FRCOphth Oxford Eye Hospital
  More Information

No publications provided

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01175070     History of Changes
Other Study ID Numbers: MIDME 001 PID 6180
Study First Received: August 2, 2010
Last Updated: June 20, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee
United Kingdom: National Health Service

Keywords provided by University of Oxford:
diabetic macular oedema
ischaemia
anti VEGF
pegaptanib
Ischaemic diabetic macular oedema

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on July 29, 2014