sing direct observation of dying retinal cells technique to predict the likelihood of macular atrophy developing in newly diagnosed wet macular degeneration patients

Not Applicable

Completed

• Conditions: Age-related macular degeneration and macular atrophy; Eye Diseases

• Registration Number: ISRCTN22122298
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-09-14
• Study Completion: 2023-12-01
• Last Update Posted: 25 March 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Adults aged =50 years
2. Best corrected visual acuity between 6/12 and 6/96 (30-70 letters)
3. Wet AMD established on FAF, optical coherence tomography angiography (OCT-A) and OCT performed at baseline
4. Absence of MA as defined per protocol
5. Undergoing standard of care wet AMD treatment
6. Treatment-naïve (no previous anti-VEGF)
7. Sufficiently clear ocular media in the studied eye
8. Adequate pupillary dilation
9. Fixation to permit quality fundus imaging
10. Ability to give informed consent
11. The ability to understand and comply with the trial consent process and procedures
12. Refractive error not higher than the spherical equivalent of +/-6 D

Exclusion Criteria

1. Previous anti-VEGF treatment
2. Geographic atrophy and macular atrophy at baseline as defined per protocol
3. Pregnant or lactating, or not using adequate contraception* for the duration of the trial (and 30 days post-injection of study drug)
4. Receiving active treatment in any studies of investigational drugs for geographic atrophy (GA)/dry AMD in the study eye
5. Co-existing glaucoma, diabetic retinopathy, macular dystrophies, hypertensive retinopathy and other retina conditions, inherited retinal conditions (such as vitelliform macular dystrophy, Stargardt, ADFVM)
6. Presence of epiretinal membrane (ERM)
7. Any evidence of ocular inflammation
8. History of retinal surgery, or other surgical intervention for AMD in the study eye
9. Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein occlusion, and proliferative diabetic retinopathy in the study eye
10. Prior treatment with Visudyne (photodynamic Therapy [PDT]), external-beam radiation therapy, or transpupillary thermotherapy in the study eye
11. History of prophylactic subthreshold laser treatment for AMD in the study eye
12. Previous intravitreal drug delivery in the study eye (e.g., intravitreal corticosteroid injection, anti-angiogenic drugs, anti-complement agents, or device implantation)
13. A single intraoperative administration of a corticosteroid during cataract surgery for cystoid
14. Any concurrent ocular or intraocular condition in the study eye (e.g., cataract or diabetic retinopathy) that, in the opinion of the investigator, could do either of the following:
14.1. Require medical or surgical intervention during the study period to prevent or treat vision loss that might result from that condition
14.2. If allowed to progress untreated, could likely contribute to the loss of visual potential in that eye
15. Previous violation of the posterior capsule in the study eye unless it occurred as a result of Yttrium Aluminum Garnet (YAG) laser posterior capsulotomy in association with prior posterior chamber intraocular lens implantation. For patients who have undergone prior refractive or cataract surgery in the study eye, the preoperative refractive error in the study eye should not have exceeded 6 diopters of myopia.
16. Intraocular surgery (including cataract surgery) in the study eye within 3 months preceding Day 1
17. History of glaucoma-filtering surgery in the study eye
18. History of corneal transplant in the study eye
19. Major surgery (major according to the investigator's assessment) performed within 12 weeks prior to randomization or planned within 12 months after screening, e.g. hip replacement
20. Currently enrolled in another investigational device or drug trial, or less than 30 days since ending another investigational device or drug trial(s), or receiving other investigational treatment(s)

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Macular atrophy development measured using the DARC CNN score at baseline, 3 and 6 months<br>2. Presence of MA measured using the DARC CNN score at 12 months

Secondary Outcome Measures

Name	Time	Method
1. Development of MA measured using OCT and FAF morphological biomarkers at 12 months<br>2. Prognostic value of CNN DARC score at baseline in relation to MA development at 12 months<br>3. Prognostic value of change from baseline of CNN DARC score at month 3 in relation to MA development at 12 months<br>4. Prognostic value of change from baseline of CNN DARC score at month 6 in relation to MA development at 12 months<br>5. OCT morphological biomarkers at baseline that correlate with MA development and their correlation to CNN DARC score