Pegaptanib Therapy in Non-Infectious Uveitic Cystoid Macular Edema

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

Summary

According to a recent estimate more than 280,000 people in the United States are affected by uveitis each year. This report, also estimated that uveitis is the reason for 30,000 new cases of blindness/year and up to 10 percent of all cases of blindness. The purpose of this trial is to determine the effectiveness of VEGF blockade with intravitreal pegaptanib in patients with uveitic CME.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest University
• Treatments: Endothelial Growth Factors

Criteria

Inclusion Criteria:

1. Male and female adults (>18 years of age) with non infectious uveitis.

2. Demonstrable (FA and/or OCT) bilateral or unilateral CME associated with uveitis of greater than 3 months but less than 1 years duration that is documented by two independent qualified observers.

3. Best corrected VA between 20/40 and 20/200 as measured by the ETDRS chart attributable to CME in the study eye.

4. Patients may be receiving systemic therapy for the treatment of their intraocular inflammation or cystoid macular edema, or may have been treated for the cystoid macular edema in the past.

5. Anterior chamber inflammation equal to or greater than 1+ and vitreous inflammation equal to or greater than 1+ cell and 1+ haze as per the 'Standardization of Uveitis' working group definition.

6. Females of child bearing potential must agree to utilize effective contraception during the study and two months after the last dose of study medication.

7. Male study patients will agree to use effective contraception.

8. Ability to give informed consent.

Exclusion Criteria:

1. Allergy to pegaptanib or any of its components

2. Diabetic retinopathy, macular degeneration or any other ocular condition affecting the study eye that may cause vision loss or in the opinion of the study investigator would interfere with the evaluation of the efficacy of Macugen for the treatment of uveitis associated CME.

3. Refusal to try the therapeutic alternative pegaptanib

4. Lack of understanding of the consent or protocol

5. Suspicion/proved history or current diagnosis, (clinical or otherwise) of infectious uveitis.

6. Need for intraocular surgery within 30 weeks of study duration.

7. Periocular steroids to the study eye less than 6 weeks prior to study enrollment

8. History of any prior intravitreal injections in study eye

9. Systemic immunomodulatory agent(s) added or increased in dosage (>20%) within the last two months prior to study enrollment, or potential need for any increase during the study.

10. Requirement for systemic corticosteroids in the equivalent of oral prednisone > 30mg/day

11. Topical prostaglandin analog use

12. Severe debilitating disease or medical problems that make consistent follow-up over the treatment period unlikely (e.g. liver impairment, stroke, severe myocardial infarction, terminal cancer).

13. History of hypersensitivity to fluorescein or multiple drug allergies that may increase the chance of a drug reaction to Macugen.

14. Unclear media that precludes assessment of cystoid macular edema in eligible eye(s), such as a cataract or vitreal opacity.

15. Evidence of a macular hole in the study eye.

16. Prior or current retinal detachment in the study eye.

17. Concurrent treatment with any new investigational drug.

18. Pregnant or lactating women (Pregnant and lactating women are excluded since pregnancy may have some effect on CME).

19. Inability to comply with the study requirements.