The timing of intra-vitreal (4mg) triamcinolone acetonide, in addition to verteporfin photodynamic therapy for choroidal neovascularisation, in age-related macular degeneration: a prospective randomised controlled trial.

Phase 1

• Conditions: Submacular choroidal neovascularisation in Age-related Macular Degeneration

• Registration Number: EUCTR2006-001386-42-GB
• Lead Sponsor: Imperial College

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-05-10
• Study Completion: 2008-06-02
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Male or female
2. The patient must be willing to give written Informed consent.
3. The patient must be able to undertake the necessary tests and treatment and be willing to be followed up.
4. Age 50 years or older.
5. Clinical diagnosis of AMD.
6. Classic, Predominantly classic or occult CNV on fluorescein angiography.
7. LogMAR visual acuity of >35 letters on a 2m or 4m EDTRS chart.
8. Does not have open angle glaucoma.
9. Is not a steroid responder for intraocular pressure

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

1. Inability to understand or sign consent form.
2. The patient has a current medical condition or history of a medical condition that would be likely to preclude scheduled study visits such as unstable angina, dialysis, active cancer.
3. Patient has a current ophthalmic condition or history of an ophthalmic condition that might compromise the assessment of the treatment such as diabetic retinopathy, uveitis, amblyopia, and ischaemic optic neuropathy.
4. Signs of a myopic retina or refraction of > -6 dioptres in their current or previous glasses prescription
5. Signs of other retinal conditions that may have caused the CNV such as angioid streaks, choroidal rupture, old chorio-retinitis.
6. At increased risk of developing glaucoma such as having; pigment dispersion syndrome or pseudo-exfoliation
7. Unable to have a good quality fluorescein angiogram taken e.g. due to; head tremor or media opacity.
8. Allergic to fluorescein or verteporfin or triamcinolone acetonide.
9. Previous treatment for a retinal detachment.
10. Judged by the examining clinician to be at increased risk of retinal detachment due to weaknesses in the peripheral retina.
11. Patient is currently participating or has participated in a clinical trial that utilized an investigational drug or treatment within 30 days prior to enrolment to this study.
12. On anticoagulation therapy such as warfarin, with the exception of aspirin and other anti-platelet therapy.
13. < 35 letters on the ETDRS logMAR chart.
14. Inability to read a logMAR chart.
15. Intraocular surgery in study eye within 60 days prior to planned enrolment in study.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess which combination of laser treatment (photodynamic therapy = PDT) and injection (of triamcinolone into the vitreous within the eye) is most effective in preventing loss of vision (visual acuity) due to submacular new vessel ingrowth in age-related macular degeneration. Untreated this condition has an almost 100% of legal blindness.<br>Patients will be allocated at random into 2 study arms.The two arms in the study are <br>1. Trimcinolone injection preceding PDT 2. PDT before the Trimcinolone injection;Secondary Objective: - Lesion size at one year, adjusted for baseline lesion size.<br>- Number of treatments required in first year after randomisation.<br>- Incidence of serious complications.<br>- Vision-specific and generic health status questionnaires: NEIVFQ(25); SF-36.<br>- Contrast sensitivity threshold (Pelli-Robson contrast sensitivity chart).;Primary end point(s): Visual acuity [VA] at 1 year (EDTRS logMAR chart at 2m, letters read), adjusted for baseline logMAR VA.