A PHASE IIIB, ONE YEAR, OPEN LABEL, MULTICENTRE, NONCOMPARATIVE STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF INTRAVITREAL PEGAPTANIB SODIUM INJECTION IN SUBJECTS WITH DIABETIC MACULAR EDEMA (DME)

• Conditions: Subjects with type I or type II diabetes with diabetic macular edema (DME) withproliferative or non proliferative diabetic retinopathy.; MedDRA version: 12.1Level: LLTClassification code 10057934Term: Diabetic macular edema

• Registration Number: EUCTR2010-020946-80-FI
• Lead Sponsor: Pfizer Inc, 235 East 42nd Street, New York, NY 10017, USA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-15
• Last Update Posted: 18 September 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Subjects must meet all of the following inclusion criteria to be eligible for enrolment into the study:
1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
2. Subjects who are willing and able to comply with scheduled visits, treatment plan,
laboratory tests, and other study procedures.
3. Subjects with documented clinical diagnosis of diabetic macular edema (DME) with
proliferative or non proliferative diabetic retinopathy.
4. Subjects, who according to the clinical assessment of the investigator, may benefit from anti-VEGF therapy including those subjects who were participating in the A5751013 study and who, in the investigator’s opinion, may benefit from continued pegaptanib sodium therapy.
5. Best corrected distance visual acuity in the study eye must be with a letter score between 78 and 24, inclusive (20/32 to 20/320 Snellen equivalents).
6. Intraocular pressure of 21 mmHg, or less.
7. The treating investigator should be comfortable that focal laser (direct and grid as
needed) can be deferred for at least 18 weeks in the study eye, even though focal or grid laser is indicated.
8. Type I or Type II diabetic subjects as defined by the WHO criteria, of either gender, and aged =18 years.
9. Women must be using effective contraception or be post-menopausal for at least 12 months prior to trial entry, or surgically sterile. All women of childbearing potential
must have a negative urine pregnancy test at baseline and negative urine pregnancy tests immediately prior to each injection and use an effective form of contraception during the trial and for at least 60 days following the last dose of pegaptanib sodium. Effective forms of contraception are: hormonal contraceptives (oral, injected, intrauterine, transdermal or implanted) or a double barrier contraception (ie condom plus spermicide in combination with a female condom, diaphragm, cervical cap or intrauterine device).
10. Clear ocular media and adequate papillary dilatation.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects presenting with any of the following will not be included in the study:
1. Eyes with prior scatter (panretinal) photocoagulation within 4 months prior to baseline or anticipated scatter (panretinal) photocoagulation within the next 6 months.
2. Any other condition which could contribute or cause macular edema such as vitreous extension, vitreomacular traction or entrapment to anterior segment wound, or any retinal vein occlusion involving the macula that could, in the investigator’s opinion, preclude benefit from pegaptanib sodium treatment.
3. Atrophy/scarring/fibrosis involving the centre of the macula, including evidence of laser treated atrophy within 200 microns of foveal avascular zone (FAZ). Any known
subfoveal hard exudates or retinal pigment epithelium (RPE) atrophy.
4. Subjects who have received YAG laser, or peripheral retinal cryoablation, or laser
retinopexy (for retinal tears only), or focal or grid photocoagulation, within the previous 16 weeks.
5. Significant media opacities, including cataract, which might interfere with visual acuity and assessment of toxicity.
6. Any intraocular surgery within 4 months of study entry.
7. Previous vitrectomy.
8. Previously documented HbA1C level >10% or recent signs of uncontrolled diabetes (3 or more episodes of severe hypoglycaemia by DCCT (Diabetes Control and Complications Trial) definition [10] within 3 months of baseline, or 2 or more episodes of ketoacidosis within 1 year of baseline, or an episode of ketoacidosis within 3 months of baseline).
9. Known serious allergies to the components of pegaptanib sodium formulation.
10. Subjects who have received either pegaptanib sodium or any other anti-VEGF agent and have not benefited from the treatment.
11. Any of the following underlying diseases including:
•History or evidence of severe cardiac disease eg. NYHA Functional Class III or IV
(eg marked limitation of activity due to fatigue, palpitation or dyspnoea, or worse),
myocardial infarction within 6 months, ventricular tachyarrythmias requiring ongoing
treatment or unstable angina.
•History of stroke within 12 months prior to baseline visit or evidence of clinically
significant peripheral vascular disease such as intermittent claudication or prior
amputation.
•Acute ocular or periocular infection.
12. Systolic BP > 160 (2 different readings) or diastolic BP > 100 (2 different readings).
13. Subjects who have received any investigational drug or device within 3 months prior to the baseline visit except for those subjects that have participated in the A5751013 study and in the investigator’s opinion may benefit from continued pegaptanib sodium therapy.
14. Other known severe acute or chronic medical or psychiatric condition or laboratory abnormality (in particular known laboratory abnormalities that may indicate impaired renal or hepatic function) that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to further evaluate the safety and tolerability of<br>pegaptanib sodium in subjects with DME.;Secondary Objective: No secondary objectives listed in the protocol.;Primary end point(s): Primary endpoint:<br>• The incidence of AEs both ocular and non-ocular.<br>Secondary endpoints:<br>• The incidence of SAEs both ocular and non-ocular.<br>• Mean total number of injections per subject.<br>• Mean changes in BCVA from baseline to end of treatment.