2-step versus 1-step sub-retinal injection to assess sub-retinal drug delivery

Not Applicable

Recruiting

• Conditions: Sub-macular haemorrhage; Eye - Diseases / disorders of the eye

• Registration Number: ACTRN12619001121156
• Lead Sponsor: The University of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-12
• Last Update Posted: 3 March 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

•Participants will be patients with either a new or an established diagnosis of age-related macular degeneration and with a 7 day or less history of vision loss secondary to sub-macular haemorrhage.
•Age greater than or equal to 18 years (Participants with sub-macular haemorrhage or retinal arteriolar macroaneurysm are typically over 60 years of age.)
•Area of haemorrhage of greater than 1 disc area but not meeting the criteria for massive sub-retinal haemorrhage (haemorrhage extending beyond the temporal vascular arcades).
•Density of haemorrhage sufficient to obscure the RPE and choroidal detail.
•Haemorrhage involving the fovea.
•BCVA equal to, or worse than 6/60
•Written informed consent has been obtained

Exclusion Criteria

•Symptoms suggestive of sub-macular haemorrhage for > 7 days.
•Amblyopia in the study eye.
•Presence of another ocular disease affecting vision in the study eye.
•Known allergy to fluorescein
•Women who are pregnant, nursing or planning pregnancy or who are of childbearing potential and not using reliable means of contraception. (A woman is considered of childbearing potential unless she is post-menopausal and without menses for 12 months or is surgically sterilised)
•Participants unable to adhere to post-operative posturing.
•BCVA < HM
•Known allergy to agents used in the study e.g. fluorescein sodium
•Known history of significant cardio-pulmonary disease
•Multiple concomitant drug therapies – in particular, beta-blockers (including eye drops)
•Patients who, in the opinion of the treating surgeon and anaesthetist, are unfit for a surgical procedure, with a condition that may put the patient at considerable risk, may confound the study results or may interfere significantly with the patient’s participation in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified