Effect of Macugen(Pegaptanib)on Surgical Outcomes and VEGF Levels in Diabetic Patients With PDR (Diabetic Retinopathy or CSDME (Macular Edema)

NCT00446381

Last updated date
Study Location
Ivey Eye Institute, St. Joseph's Health Care Centre
London, Ontario, N6A 4G5, Canada
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Proliferative Diabetic Retinopathy, Diabetic Macular Edema
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 18 years or older

- Type 1 or 2 diabetes

- patients requiring surgical intervention for complications of proliferative diabetic retinopathy with vitreous hemorrhage or traction retinal detachment or clinically significant macular edema

- women postmenopausal for 12 months before the study, surgically sterile, or not pregnant and on effective contraception.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- previous retinal vein occlusion.


- any intraocular surgery within the previous 12 months.


- myopia of > or = to 8 diopters.


- active ocular or periocular infection


- treatment with an investigational agent for any condition 60 days prior to enrollment.


- evidence of severe cardiac disease.


- clinically significant peripheral vascular disease (previous surgery, amputation, or
symptoms of claudication)


- uncontrolled hypertension (treated systolic blood pressure > 155 mmHg or diastolic
blood pressure > 95 mmHg)


- stroke within the preceding 12 months.

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Proliferative Diabetic Retinopathy, Diabetic Macular EdemaEffect of Macugen(Pegaptanib)on Surgical Outcomes and VEGF Levels in Diabetic Patients With PDR (Diabetic Retinopathy or CSDME (Macular Edema)
NCT00446381
  1. London, Ontario
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Effect of Macugen(Pegaptanib)on Surgical Outcomes and VEGF Levels in Diabetic Patients With PDR (Diabetic Retinopathy or CSDME (Macular Edema)
Official Title  ICMJE Effect of Macugen (Pegaptanib) on Surgical Outcomes and Growth Factors Including Vascular Endothelial Growth Factor (VEGF) Levels in Patients With Proliferative Diabetic Retinopathy (PDR) and Clinically Significant Diabetic Macular Edema (CSDME)
Brief Summary Patients with proliferative diabetic retinopathy or clinically significant diabetic macular edema requiring surgical intervention will receive a pre-operative injection of Macugen. An initial, pre-injection vitreous tap will be done in order to provide baseline VRGF 165 and cytokine levels. At the onset of the vitrectomy, a second vitreous sample will be taken to obtain intra-operative levels of Macugen, VEGF 165 and cytokines.
Detailed Description

Diabetes is one of the leading causes of blindness in North America. Diabetic retinopathy (PDR) is characterized by disruption of the normal microvascular circulation in the retina and results in the production of neovascularization and increased microvascular permeability. Similarly, clinically significant diabetic macular edema CSDME) results in loss of central visual acuity.

Many patients with these conditions, despite treatment, will go on to develop vitreous hemorrhage or tractional changes that require surgical intervention (such)as vitrectomy and/or vitrectomy with membrane peeling in the attempt to both restore vision and prevent further visual loss or re-establish the normal macular anatomy and improve patient visual acuity.

Although multiple etiologic factors are involved in the early changes seen in diabetic retinopathy and maculopathy, it has been shown that VEGF is the primary angiogenic growth factor implicated in the development of neovascularization in PRD and in increased vascular permeability, resulting in CSDME. VEGF levels have been found to correlate tightly with the extent of diabetic retinopathy and introduction of VEGF into normal primate eyes can induce diabetic retinopathy. Although several isoforms of VEGF exist, isoform 165 (VEGF 165) is the most pathogenic form of VEGF and therefore inhibition of VEGF 165 may play a significant role in modulating diabetic retinopathy and maculopathy.

Macugen is a VEGF antagonist (anti-VEGF pegylated aptamer) which binds to VEGF 165 with high specificity and affinity. In vitro pharmacology studies have shown that Macugen binds to the amino acid isoform VEGF 165 and inhibits it from binding to its cellular receptors. As a consequence, Macugen blocks signalling events and disrupts the cascade of proliferative and vascular permeability responses associated with the binding of VEGF 165 to endothelial cells. This effect has been clearly proven in Phase 3 trials for patients with age-related macular degeneration (AMD), resulting in inhibition of vascular development and decrease in vascular leakage.

Although diabetic retinopathy represents a different challenge than AMD, the underlying pathogenic factors are similar in the role and effects of VEGF. Regression of retinal neovascularization after Macugen therapy in diabetic individuals has been shown. Phase 2 studies have been completed and Phase 3 studies are currently underway in patients with diabetic macular edema to evaluate the efficacy of Macugen to restore vision in patients with CSDME. These studies are ongoing but exclude patients in whom vitrectomy has been performed or is planned in the near future due to tractional effects on the macula from epiretinal membranes or vitreomacular traction syndrome. No studies have been done to date in patients with PDR or CSDME to quantify the reduction of intravitreal VEGF 165 levels in these patients following intravitreal Macugen injection or to evaluate the effects of VEGF 165 blockade on the neovascular regression and surgical outcome in patients with extensive diabetic proliferative neovascularization.

The goal of this study is to quantify the reduction of intravitreal VEGF 165 levels in patients following intravitreal Macugen injection pre-operatively and determine the level of Macugen in the vitreous cavity after variable time intervals (2,4, 6 or 8 weeks).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Proliferative Diabetic Retinopathy
  • Diabetic Macular Edema
Intervention  ICMJE
  • Drug: Macugen (pegaptanib)
    Pegaptanib 0.3 mg by intravitreal injection once pre-operatively
  • Drug: Macugen (Pegaptanib)
    Pegaptanib 0.3 mg by intravitreal injection once pre-operatively.
Study Arms  ICMJE
  • Experimental: 1
    Patients with Proliferative Diabetic Retinopathy
    Intervention: Drug: Macugen (pegaptanib)
  • Experimental: 2
    Patients with Clinically Significant Macular Edema
    Intervention: Drug: Macugen (Pegaptanib)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 8, 2009)
28
Original Enrollment  ICMJE
 (submitted: March 9, 2007)
32
Actual Study Completion Date  ICMJE September 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18 years or older
  • Type 1 or 2 diabetes
  • patients requiring surgical intervention for complications of proliferative diabetic retinopathy with vitreous hemorrhage or traction retinal detachment or clinically significant macular edema
  • women postmenopausal for 12 months before the study, surgically sterile, or not pregnant and on effective contraception.

Exclusion Criteria:

  • previous retinal vein occlusion.
  • any intraocular surgery within the previous 12 months.
  • myopia of > or = to 8 diopters.
  • active ocular or periocular infection
  • treatment with an investigational agent for any condition 60 days prior to enrollment.
  • evidence of severe cardiac disease.
  • clinically significant peripheral vascular disease (previous surgery, amputation, or symptoms of claudication)
  • uncontrolled hypertension (treated systolic blood pressure > 155 mmHg or diastolic blood pressure > 95 mmHg)
  • stroke within the preceding 12 months.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00446381
Other Study ID Numbers  ICMJE R-06-821
Health Canada Control #108753
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Thomas G. Sheidow, Lawson Health Research Institute
Study Sponsor  ICMJE Lawson Health Research Institute
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Thomas G. Sheidow, MDIvey Eye Institute, St. Joseph's Health Care Centre
PRS Account Lawson Health Research Institute
Verification Date April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP