Prospective, Randomized, Open Label, Phase II Study to Assess Efficacy and Safety of Macugen® (Pegaptanib 0.3 mg Intravitreal Injections) Plus Panretinal Photocoagulation and PRP (Monotherapy) in the Treatment With High Risk PDR.
2 other identifiers
interventional
22
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2010
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 20, 2011
CompletedFirst Posted
Study publicly available on registry
January 21, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedMarch 19, 2015
April 1, 2013
2.6 years
January 20, 2011
March 18, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (8)
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
Changes from baseline in Visual Fields
12-month treatment
Recurrence of retinal neovascularization
12-month treatment
Number of treatments needed
12-month treatment
- +3 more secondary outcomes
Study Arms (2)
Panretinal Photocoagulation (PRP)
ACTIVE COMPARATORGroup 1: Panretinal photocoagulation treatment (PRP) at week-0 that can be repeated every 6 weeks.
Pegaptanib + Panretinal Photocoagulation (PRP)
EXPERIMENTALGroup 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.
Interventions
Panretinal Photocoagulation (PRP)
Intravitreous injection of pegaptanib
Eligibility Criteria
You may qualify if:
- High-risk proliferative diabetic retinopathy (HR-PDR) eyes (as defined in section 2).
- BCVA at baseline \> 20/320 (25 letters in the ETDRS Chart) in the study eye.
- Clear ocular media and adequate pupillary dilatation to permit good quality fundus photography.
- Intraocular pressure \< 21 mmHg.
- Type I, or Type II diabetic subjects as defined by the WHO criteria of either gender, and aged ≥ 18 years.
- Women must be using effective contraception, be post-menopausal for at least 12 months prior to trial entry, or surgically sterile.
- Ability to provide written informed consent.
- Ability to return for all trial visits.
You may not qualify if:
- Eyes with prior scatter (panretinal).
- Focal/grid photocoagulation, within the previous 6 months.
- Fibrovascular proliferation with retinal traction.
- Other cause of retinal neovascularization (retinal vein occlusion, radiation retinopathy or others).
- Atrophy/scarring/fibrosis/ hard exudates involving the center of the macula.
- Subjects who have received YAG laser within the previous 6 months.
- Peripheral retinal cryoablation, or laser retinopexy (for retinal tears only),
- Significant media opacities, which might interfere with visual acuity, assessment of toxicity or fundus photography.
- Subjects should not be entered if there is likelihood that they will require cataract surgery within the following 1 year.
- Any intraocular surgery within 6 months before trial enrolment.
- Previous vitrectomy.
- HbA1C level \>11% or recent signs of uncontrolled diabetes.
- Any of the following underlying systemic diseases:
- History or evidence of severe cardiac disease, e.g. NYHA Functional Class III or IV, clinical or medical history of unstable angina, acute coronary syndrome, myocardial infarction, or revascularization procedure within 6 months prior to baseline, or ventricular tachyarrhythmia requiring treatment.
- History or evidence of clinically significant peripheral vascular disease such as intermittent claudication or prior amputation.
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center for Clinical Trials - Aibili
Coimbra, 3000-548, Portugal
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2011
First Posted
January 21, 2011
Study Start
March 1, 2010
Primary Completion
October 1, 2012
Study Completion
February 1, 2013
Last Updated
March 19, 2015
Record last verified: 2013-04