Combination Therapy for Age-Related Macular Degeneration.

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of the study is to investigate whether patients with Choroidal Neovascularization secondary to Age-related Macular Degeneration, receiving triple or double therapy compared to monotherapy with Avastin will reduce the intervention rate with equivalent safety and efficacy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lawson Health Research Institute
• Collaborators: Canadian Retinal Trials Group; QLT Inc.
• Treatments: Bevacizumab; Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

Criteria

Inclusion Criteria:

1. Choroidal neovascularization (CNV) secondary to age-related macular. All lesion subtypes, based upon IVFA evaluation will be included.

2. CNV under the geometric centre of the foveal avascular zone.

3. Evidence of choroidal neovascular activity as suggested by one of the following:

sub-retinal lipid, sub-retinal hemorrhage, and documented loss of 3 lines of vision within the last three months.

4. Greatest linear dimension of the lesion

5. Visual acuity of between 20/32 and 20/800 in the study eye - Equivalent to Early Treatment of Diabetic Retinopathy Study (ETDRS) eye chart score of 5 to 75 letters at 2 metres.

6. Willingness and ability to participate and provide written informed consent

Exclusion Criteria:

1. Individuals with choroidal neovascularization from causes other than AMD.

2. Individuals physically unable to tolerate intravenous fluorescein angiography or Verteporfin injections. (Specifically, individuals with inadequate venous access or an allergy/sensitivity to fluorescein dye/porphyrins will be excluded.)

3. Any intraocular surgery within 3 months in the study eye.

4. Prior retinal or vitreous surgery including posterior segment vitrectomy or scleral buckling in the study eye.

5. Any significant ocular disease that has compromised or could compromise vision in the study eye and confound analysis of the primary outcome.

6. Individuals with physical or mental disabilities that prevent accurate vision testing.

7. History of treatment of CNV in study eye other than extrafoveal confluent laser photocoagulation.

8. Prior photodynamic therapy for CNV in the study eye.

9. Active hepatitis or clinically significant liver disease

10. Any patient with recent history of new onset cardiac disease or thromboembolic CNS event in the past.

11. Subjects who are in an experimental therapy study or who have received experimental therapy within the last 12 weeks.

12. Subjects who are a poor medical risk because of other systemic diseases or active uncontrolled infections.

13. Women of child-bearing potential who are not on two forms of effective contraception during the trial and for at least 60 days following the last dose of study medications.