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)

Phase 3

Withdrawn

Conditions: Diabetic Retinopathy
swelling of the retina
10047060

Registration Number: NL-OMON36645

Lead Sponsor: Pfizer

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

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.
10. Clear ocular media and adequate papillary dilatation.

Exclusion Criteria

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).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The incidence of AEs both ocular and non-ocular.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- The incidence of SAEs both ocular and non-ocular.<br /><br>- Mean total number of injections per subject.<br /><br>- Mean changes in BCVA (Visual Acuity Assessment) from baseline to end of<br /><br>treatment.</p><br>