Neovascular age-related macular degeneration (nAMD) Eye Diseases Degeneration of macula and posterior pole
Conditions
Interventions
Patients presenting to secondary care with suspected nAMD will undergo an OCT. If nAMD is clinically suspected following an OCT, the patient will have two more tests: OCTA and FA.
Patients with cli
Sponsors
Moorfields Eye Hospital NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients presenting to secondary/specialist care centres with suspicion of nAMD in the first or second eye 2. Can provide informed consent 3. Have the ability to perform study-specific procedures
Exclusion criteria
Exclusion criteria: 1. Significant media opacities (cataract, vitreous opacities) that would not allow good quality fundus imaging 2. Diabetic retinopathy of severity worse than mild non-proliferative stage and with any degree of diabetic maculopathy 3. Other causes of choroidal neovascularisation (myopic, angioid streaks, inflammatory, retinal dystrophies, secondary to central serous chorioretinopathy, idiopathic) 4. Inability to undergo dye-based imaging (FA or ICGA) due to history of allergy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The sensitivity and specificity of the index tests, OCTA combined with OCT and FA combined with OCT, for the detection of nAMD in participants with a positive or suspicious OCT at baseline. Sensitivity and specificity are defined respectively as the proportion of participants with nAMD that are correctly identified by the index tests as cases and the proportion of participants without nAMD that are correctly identified by the index tests as non-cases. The index tests are interpreted by clinicians (retinal experts) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The sensitivity and specificity of the index tests, OCTA alone and FA alone, for the detection of nAMD in participants with a positive or suspicious OCT at baseline. The positive predictive value (PPV) and negative predictive (NPV) of OCTA alone and FA alone are defined respectively as the proportion of participants with a positive index test result that have nAMD and the proportion of participants with a negative index test result that do not have nAMD. OCTA and FA are interpreted separately by Reading Centre expert graders. 2. The PPV of OCT for detection of nAMD in all patients presenting with suspicion of nAMD at baseline (test interpretation by retinal experts and Reading Centre graders) 3. The difference in sensitivity and difference in specificity of OCT+FA and OCT+FA+OCTA at baseline reviewed by retinal experts within the ‘OCT+FA’ arm of the study 4. The difference in sensitivity and difference in specificity of OCT+OCTA and OCT+FA+OCTA at baseline reviewed by retinal experts within the ‘OCT+OCTA’ arm of the study 5. The sensitivity, specificity, PPV and NPV of OCTA, FA, ICGA, alone and in combinations, for detection of PCV in patients with OCT and clinical features suspicious of PCV at baseline 6. Intra- and inter-rater variation in the assessment of OCTA and FA by scans taken at baseline and assessed by Reading Centre graders at a later date 7. Criteria for OCTA-based diagnosis of nAMD determined using a consensus process at baseline 8. Incremental cost per true positive detected and incremental cost per correct diagnosis for nAMD estimated through cost-effectiveness analysis 9. The sensitivity, specificity, PPV and NPV of OCTA for detection of nAMD by lesion type as assessed by Reading Centre expert graders (PCV, type 1-, type 2-, type 3- nAMD) at baseline. 10. The limitations of OCTA use and adverse events summarised descriptively as they occur throughout the study | — |
Countries
England, United Kingdom
Outcome results
None listed