A Single-Center Trial of Intravitreous Injections of Macugen (Pegaptanib Sodium) Given at Least 7 Days Before Vitrectomy Secondary To Tractional Retinal Detachment in Proliferative Diabetic Retinopathy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Retina Institute of Hawaii
ClinicalTrials.gov Identifier:
NCT01487070
First received: December 5, 2011
Last updated: NA
Last verified: April 2011
History: No changes posted
  Purpose

Primary objective of this trial will be to evaluate the safety and efficacy of intravitreal injections of Macugen (pegaptanib sodium) when given at least 7-14 days prior to vitrectomy in subjects with tractional retinal detachment (with or withoutmacular involvement) secondary to proliferative diabetic retinopathy.

Secondary objective is to evaluate regression of neovascularization and progression of macular traction utilizing OCT and fundus photographs.


Condition Intervention Phase
PDR
Drug: Macugen (Pegaptanib Sodium)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single-Center Trial of Intravitreous Injections of Macugen (Pegaptanib Sodium) Given at Least 7 Days Before Vitrectomy Secondary To Tractional Retinal Detachment in Proliferative Diabetic Retinopathy

Resource links provided by NLM:


Further study details as provided by Retina Institute of Hawaii:

Primary Outcome Measures:
  • Evidence of advancement of tractional detachment post injection of Macugen before surgical intervention. [ Time Frame: 7-14 days prior to surgical intervention ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluate regression of neovascularization and progression of macular traction utilizing OCT and Fundus photographs [ Time Frame: 7-14 days prior to surgical intervention ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: April 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Macugen (Pegaptanib Sodium)
Open-label, single-center trial. Subjects will recieve intravitreous injections of Macugen 7-14 days before Vitrectomy.
Drug: Macugen (Pegaptanib Sodium)

Pegaptanib sodium drug substance is a pegylated (40 kDa branched PEG molecule consisting of two 20 kDa PEG arms) anti-VEGF aptamer. It is formulated in phosphate buffered saline at pH 6-7. Sodium hydroxide or hydrochloric acid may be added for pH adjustment.

Pegaptanib sodium is formulated at 0.3mg/90µl and presented in a USP Type I glass barrel syringe sealed with a bromobutyl rubber stopper. A 30-guage needle is fixed to the end of the syringe after removal of the rubber stopper. The syringe comes in a sealed foil pouch, and the 30-gauge needle is added to the sterile injection field separately. The drug product is preservative-free and intended for single use by intravitreous injection only.


  Eligibility

Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects of either gender aged 75 years or below diagnosed with tractional retinal detachment secondary to proliferative diabetic retinopathy.

Exclusion Criteria:

  • Subjects with vitreous hemorrhage obscuring the posterior pole will be excluded.
  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: NCT01487070

Locations
United States, Hawaii
Retina Institute of Hawaii
Honolulu, Hawaii, United States, 96815
Sponsors and Collaborators
Retina Institute of Hawaii
  More Information

No publications provided

Responsible Party: Retina Institute of Hawaii
ClinicalTrials.gov Identifier: NCT01487070     History of Changes
Other Study ID Numbers: RIH1005
Study First Received: December 5, 2011
Last Updated: December 5, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetic Retinopathy
Retinal Detachment
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 01, 2014