NCT01281098|CompletedPhase 2
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Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
NIH
interventional
22
1 country
1
Study Start
March 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2012
Actual (reported)Study Completion
February 2013
Actual (reported)To evaluate the safety and determine the efficacy of PRP monotherapy or combination therapy (pegaptanib 0.3 mg plus PRP) in patients with Type I or Type II diabetes mellitus and with high risk proliferative diabetic retinopathy.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2013
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2010
Date type not reportedThis date has not been verified as actual or estimated.
January 20, 2011
Actual (reported)January 21, 2011
Actual (reported)October 2012
Actual (reported)February 2013
Actual (reported)Regression of retinal neovascularization
Retinal neovascularization will be measured in disc area units, and progression of neovascularization will be defined as an increasing of 0.5 disc area associated or not with vitreous haemorrhage, and/or pre-retinal haemorrhage, and/or rubeosis, and/or traccional retinal detachment.
12-month treatment
Changes from baseline in Best-Corrected Visual Acuity (BCVA)
12-month treatment
Changes from baseline in macular retinal thickness by Optical Coherent Tomography (OCT)
12-month treatment
Group 1: Panretinal photocoagulation treatment (PRP) at week-0 that can be repeated every 6 weeks.
Group 2: Combination treatment of pegaptanib intravitreous injections at weeks 0, 6 and 12 that can be repeated every 6 weeks. Plus PRP after first injection (2 weeks +/- 1 week)and that can be repeated every 12 weeks.
Panretinal Photocoagulation (PRP)
Intravitreous injection of pegaptanib
Center for Clinical Trials - Aibili
Coimbra, 3000-548, Portugal
22 participants (actual enrollment reported by the registry).
First Submitted
January 20, 2011
First Posted
January 21, 2011
Study Start
March 2010
Date type not reportedThis date has not been verified as actual or estimated.
Changes from baseline in Visual Fields
12-month treatment
Recurrence of retinal neovascularization
12-month treatment
Number of treatments needed
12-month treatment
Contact the study team to confirm eligibility.
Primary Completion
October 2012
Actual (reported)Study Completion
February 2013
Actual (reported)Last Updated
March 19, 2015
Record last verified: 2013-04
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Source: ClinicalTrials.gov.
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