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Completed

NCT Number: NCT01487070

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

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.

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Key information

Conditions

PDR

Age range

Up to 75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Retina Institute of Hawaii

Honolulu, Hawaii, 96815, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Macugen (Pegaptanib Sodium)

Drug

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.

Primary outcomes

  1. Evidence of advancement of tractional detachment post injection of Macugen before surgical intervention.

    Time frame: 7-14 days prior to surgical intervention

Secondary outcomes

  1. Evaluate regression of neovascularization and progression of macular traction utilizing OCT and Fundus photographs

    Time frame: 7-14 days prior to surgical intervention

Sponsors and collaborators

Lead sponsor

Retina Institute of Hawaii

Other

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Dec 7, 2011
Registry last updated
Dec 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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