Status:
COMPLETED
Intravitreal tPA and C3F8 for the Treatment of Submacular Haemorrhage as a Complication of Neovascular AMD
Lead Sponsor:
King's College Hospital NHS Trust
Conditions:
Exudative Macular Degeneration
Retinal Hemorrhage
Eligibility:
All Genders
50+ years
Phase:
PHASE2
PHASE3
Brief Summary
This study will recruit patients who have recently had a submacular haemorrhage (bleed under the part of the retina responsible for detailed vision), as a complication of wet age-related macular degen...
Detailed Description
Age-related macular degeneration (AMD) is the commonest cause of blindness worldwide. Its prevalence increases with age, being relatively rare under 60 years and reaching its peak incidence in those o...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Adults of either sex aged 50 years and older;
- SMH associated with treatment-naive or previously treated wet AMD, including retinal angiomatous proliferation (RAP) and idiopathic polypoidal choroidal vasculopathy (IPCV);
- SMH of at least 1 disc area, involving the fovea, and of sufficient density to obscure RPE detail;
- Written informed consent to participate in the study.Only one eye will be eligible for inclusion in this study.
- 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 interventional 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;
- Patients who, in the opinion of the Investigator, would not be willing or able to comply with the study protocol, including posturing requirements.
- Patients who show insufficient understanding of the clinical trial or treatment options.
Exclusion
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT01835067
Start Date
September 1 2014
End Date
December 1 2019
Last Update
July 14 2020
Active Locations (5)
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1
Maidstone Hospital
Maidstone, Kent, United Kingdom, ME16 9QQ
2
Sunderland Eye Infimary
Sunderland, Tyne and Wear, United Kingdom, SR2 9HP
3
Hull & East Yorkshire Hospital NHS Trust
Hull, United Kingdom, HU3 2JZ
4
King's College Hospital NHS Foundation Trust
London, United Kingdom, SE5 9RS