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Intravitreal Macugen for Ischaemic Diabetic Macular Oedema (MIDME)

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. Identifier: NCT01175070
Recruitment Status : Completed
First Posted : August 4, 2010
Last Update Posted : December 24, 2014
Information provided by (Responsible Party):
University of Oxford

Brief Summary:

Diabetic macular oedema (DME) is one of the leading causes of blindness in the United Kingdom'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 or disease Intervention/treatment Phase
Diabetic Macular Oedema Drug: Intravitreal injection of pegaptanib sodium Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : January 2011
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Change in size of FAZ at 30 weeks [ Time Frame: 30 weeks ]

Secondary Outcome Measures :
  1. Change in central foveal thickness and best corrected visual acuity at 30 weeks. [ Time Frame: 30 weeks ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01175070

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United Kingdom
Oxford Eye Hospital
Oxford, Oxfordshire, United Kingdom, OX3 9DU
Sponsors and Collaborators
University of Oxford
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Principal Investigator: Victor Chong, MPhil, MD, FRCSEd, FRCOphth Oxford Eye Hospital
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Responsible Party: University of Oxford Identifier: NCT01175070    
Other Study ID Numbers: MIDME 001 PID 6180
First Posted: August 4, 2010    Key Record Dates
Last Update Posted: December 24, 2014
Last Verified: December 2014
Keywords provided by University of Oxford:
diabetic macular oedema
anti VEGF
Ischaemic diabetic macular oedema
Additional relevant MeSH terms:
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Macular Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases