Stage 3 Age Related Macular Degeneration (AREDS Classification) Clinical Trial
— PREVISIONOfficial title:
Assessment Using Microperimetry of the Risk of a Fellow Eye Progressing From Stage 3 to Stage 4 (AREDS Classification) Age-related Macular Degeneration (AMD)
| NCT number | NCT02395757 |
| Other study ID # | 2014.862 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | September 2015 |
| Est. completion date | January 8, 2020 |
| Verified date | October 2016 |
| Source | Hospices Civils de Lyon |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Age-related macular degeneration (AMD) is an acquired retinal pathology affecting the central region of the retina responsible for discrimination between high spatial frequencies (reading), colour vision and the central visual field. The loss of visual acuity which occurs with the onset of AMD significantly affects patients' quality of life. In developed countries, AMD is the leading cause of vision impairment for people aged over 50 years. Its prevalence in Europe in people aged over 65 years is 3.3%. In France, around 2 million people suffer from this disease. In the first stage of the disease it is known as age-related maculopathy (ARM). This early form of the disease can develop into intermediate AMD (stage 3 of the AREDS classification) and then advanced AMD (stage 4 AREDS), which can be atrophic or exudative. In cases of exudative AMD, the intravitreal administration of anti-VEGF drugs can limit the disease's progression. It is therefore vital to adopt a strategy to assess the stage of the disease and provide the appropriate care management at the earliest possible stage. This is even more important for patients with advanced AMD in one eye and intermediate AMD in the fellow eye, as the risk of the fellow eye progressing to the advanced stage within 5 years is between 35% and 53%. Microperimetry is a promising new diagnostic method which combines measurements of light sensitivity, loss of fixation and the anatomy of the retina. It offers a new approach to the functional assessment of retinal damage in patients with AMD, as it precisely correlates anatomical and functional modifications by measuring the loss of sensitivity and macular fixation. It has been shown that the more advanced the patient's AMD is, the further the parameters measured by microperimetry are from the norm. The investigators want to assess the MAIA™ as a means of screening for AMD progression in patients with a high risk of progressing to a more advanced stage (patients presenting one eye with advanced AMD and a fellow eye with stage 3 AMD according to the AREDS classification). The research hypothesis for our proposed study is that the parameters measured using microperimetry will already show abnormal results in the study eye prior to progressing to a more advanced stage of the disease. The use of these microperimetric parameters as predictor of progression would therefore make it possible to screen eyes likely to develop from intermediate to advanced AMD at an earlier stage, and subsequently provide patients who need it with earlier follow-up, preventive treatment or adapted, personalized rehabilitation as appropriate.
| Status | Completed |
| Enrollment | 182 |
| Est. completion date | January 8, 2020 |
| Est. primary completion date | September 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 50 Years and older |
| Eligibility | Inclusion Criteria: - Patient aged 50 years or over; - Patient who has given their free, informed, signed consent; - Patient with a French social security number or equivalent cover; - Patient presenting one eye with stage 4 AMD (according to the AREDS classification), and drusen in the fellow eye (study eye) with at least one drusen with a diameter of over 125 microns and/or extra- foveal atrophy (stage 3 AREDS); - Patient who is willing and able to attend all the clinical appointments required for the study and complete all the related procedures. Exclusion Criteria: - Patient aged under 50 years; - Patient who refuses to take part in the study; - Woman who is pregnant or breastfeeding; - Protected adult as set out in French law (French Public Health Law); - Patient presenting a study eye with stage 1, 2 or 4 AMD (AREDS classification); - Patient presenting another maculopathy in the study eye; - Area alteration (cornea, lens, vitreous humour) which makes it impossible to carry out and interpret the microperimetry correctly; - Patient due to undergo cataract surgery in the study eye during the 2-year study period; - Patients who cannot be followed up for the full 2 years; - Patients participating simultaneously in other studies which may interfere with the study results (in either eye). |
| Country | Name | City | State |
|---|---|---|---|
| France | Hospice Civils de Lyon | Lyon |
| Lead Sponsor | Collaborator |
|---|---|
| Hospices Civils de Lyon | Novartis |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The sensitivity of the microperimetric parameter(s) and combination(s) of parameters according to patient status at final assessment. | The sensitivity of the microperimetry diagnostic tool will be measured by the ratio between the number of patients presenting both positive microperimetric parameters and advanced AMD (stage 4); and the total number of patients with advanced AMD diagnosed at final assessment. | 24 months | |
| Secondary | The specificity of the microperimetric parameter or combination of parameters with the highest level of sensitivity | The specificity of the microperimetry diagnostic tool will be measured by the ratio between the number of patients presenting both negative microperimetric parameters and no advanced AMD (stage 4); and the total number of patients with no advanced AMD diagnosed at final assessment. | 24 months after inclusion | |
| Secondary | The positive predictive value of the microperimetric parameter or combination of parameters with the highest level of sensitivity | The positive predictive value of the microperimetry diagnostic tool will be measured by the ratio between the number of patients presenting both positive microperimetric parameters and advanced AMD (stage 4); and the total number of patients with positive microperimetric parameters. | 24 months after inclusion | |
| Secondary | The negative predictive value of the microperimetric parameter or combination of parameters with the highest level of sensitivity | The negative predictive value of the microperimetry diagnostic tool will be measured by the ratio between the number of patients presenting both negative microperimetric parameters and no advanced AMD (stage 4); and the total number of patients with negative microperimetric parameters. | 24 months after inclusion | |
| Secondary | The sensitivity of the microperimetric parameters associated with the parameters from other ophthalmological examinations. | The parameters of other ophthalmological examinations considered will be as follows: best corrected visual acuity measured according to ETDRS (number of letters) and Snellen scales; foveolar thickness, central 1-mm thickness, external limiting membrane (ELM) integrity, and ellipsoidal line integrity measured using SD-OCT (spectral domain optical coherence tomography). The sensitivity will be measured by the ratio between the number of patients presenting both positive parameters and advanced AMD (stage 4); and the total number of patients with advanced AMD diagnosed at final assessment. | 24 months after inclusion | |
| Secondary | The specificity of the microperimetric parameters associated with the parameters from other ophthalmological examinations. | The parameters of other ophthalmological examinations considered will be as follows: best corrected visual acuity measured according to ETDRS (number of letters) and Snellen scales; foveolar thickness, central 1-mm thickness, external limiting membrane (ELM) integrity, and ellipsoidal line integrity measured using SD-OCT. The specificity will be measured by the ratio between the number of patients presenting both negative parameters and no advanced AMD (stage 4); and the total number of patients with no advanced AMD diagnosed at final assessment. | 24 months after inclusion | |
| Secondary | The sensitivity of the microperimetric parameters or combinations of parameters for the sub-group of eyes presenting reticular pseudodrusen at inclusion. | The sensitivity will be measured by the ratio between the number of patients presenting both positive parameters and advanced AMD (stage 4); and the total number of patients with advanced AMD diagnosed at final assessment. | 24 months after inclusion | |
| Secondary | The specificity of the microperimetric parameters or combinations of parameters for the sub-group of eyes presenting reticular pseudodrusen at inclusion. | The specificity will be measured by the ratio between the number of patients presenting both negative parameters and no advanced AMD (stage 4); and the total number of patients with no advanced AMD diagnosed at final assessment. | 24 months after inclusion |