Intravitreal Aflibercept for the treatment of previously treated exudative age-related macular degeneration

A prospective, open-label clinical trial, to evaluate the efficacy of intravitreal Aflibercept for the treatment of previously treated exudative age-related macular degeneration

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000666820

Enrollment

Registered

2012-06-21

Start date

2012-07-15

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of the study is to evaluate the effectiveness of intravitreal Aflibercept in the treatment of choroidal neovascularisation secondary to age-related macular degeneration. The hypothesis of this study is that intravitreal Aflibercept injection may be effective in causing resolution of persistent sub or intraretinal fluid in patients with previous treatment of Lucentis or Avastin.

Interventions

All participants will initially receive 2.0mg Aflibercept intravitreal injections every month for 3 months and then every two months for the next 9 months. The overall duration of this treatment is 1 year.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

50 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Ability to provide informed consent and complying with the study assessments who are the 2. Age 50 years or older 3. Choroidal neovascularization secondary to age-realted macular degeneration 4. Best corrected vision between 6/6 to 6/60 on EDTRS chart 5. Presence of subretinal fluid or cystic intraretinal oedema on optical coherence tomography after at least 4 anti-VEGF treatments within minimum of 6 months and maximum of 3 years before enrollment of the study 6. Documentation of the presence of subretinal fluid or cystoid oedema less than 30 days since last treatment.

Exclusion criteria

1. Pregnancy or lactation 2. Premenopausal women not using contraception 3. Prior anti-VEGF injection in the study eye within 30 days of baseline 4. Prior treatment with PDT (Visudyne) within 90 days of baseline and more than 6 prior PDT treatments 5. Significant subretinal fibrosis or atrophy 6. Prior treatment with triamcinolone in the study eye within 6 months of baseline 7. Intraocular surgery in the study eye within 2 months of baseline 8. Prior vitrectomy or other surgical intervention for age-realted macular degeneration in the study eye 9. Current vitreous haemorrhage or inflammation in the study eye 10. Uncontrolled glaucoma I the study eye. Intraocular pressure greater than 30mmHg on maximal medical therapy 11. History of stroke, acute myocardial infarction and transient ischemic attack within 3 months of study enrollment 12. Allergy to fluorescein and indocyanine green dye.

Outcome results