Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT01835067
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT01835067
Study Brief:
Protocol Section:
NCT01835067