A clinical trial of a clot dissolving drug and gas, injected into the eye, to treat bleeding associated with wet age-related macular degeneratio

Phase 1

Active, not recruiting

• Conditions: Sub-macular haemorrhage secondary to wet macular degeneration; MedDRA version: 16.0Level: PTClassification code 10064930Term: Age-related macular degenerationSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 16.0Level: LLTClassification code 10067791Term: Wet macular degenerationSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2012-004078-24-GB
• Lead Sponsor: King's College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-22
• Study Completion: 2019-11-15
• Last Update Posted: 2024-09-09

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

- Adults of either sex aged 50 years and older;
- SMH associated with treatment naive or previously treated wet AMD;
- SMH involving the fovea and of sufficient density to obscure RPE detail.
- Able to give informed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 55
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 55

Exclusion Criteria

- SMH that is known to have been present for greater than 2 weeks duration, as evidenced by history, pre-trial documentation, or fundus appearance;
- Presence of significant vitreous haemorrhage precluding accurate retinal assessment in the study eye;
- Diabetic maculopathy in the study eye;
- Visually significant cataract in the study eye;
- Amblyopia in the study eye;
- Presence of other ocular disease causing concurrent vision loss in the study eye;
- Advanced glaucoma in the study eye (cup-to-disc ratio greater than 0.8);
- Pregnant and or lactating women;
- Women of childbearing potential including those who are not sterilised or at least one year post menopausal;
- Participation in a clinical trial in the preceding 6 months;
- Documented evidence of a visual acuity less than 25 ETDRS letters at three consecutive visits in the study eye, prior to the onset of submacular haemorrhage;
- Participants who are known to have been ineligible for NICE approved ranibizumab therapy prior to the development of the SMH;
- Current treatment for wet age-related macular degeneration with an intravitreal agent other than ranibizumab, bevacizumab or aflibercept;
- Participants who, in the opinion of the Investigator, would not be willing or able to comply with the study protocol, including posturing requirements.
- Unable to give informed consent

Study & Design

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