A Study Assessing Corneal Endothelial Cells in Participants With Neovascular Age-related Macular … (NCT04853251) | Clinical Trial Compass
RecruitingPhase 4
A Study Assessing Corneal Endothelial Cells in Participants With Neovascular Age-related Macular Degeneration (nAMD) Treated With the Port Delivery System With Ranibizumab (PDS)
United States188 participantsStarted 2021-12-14
Plain-language summary
This study will assess corneal endothelial cells in participants with nAMD treated with PDS refilled every 24 weeks (Q24W).
Who can participate
Age range50 Years
SexALL
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Inclusion Criteria
Ocular Inclusion Criteria:
* Diagnosis of nAMD prior to screening as determined by the investigator
* Difference of \<10% in ECD at screening between the 2 eyes as measured by specular microscopy and determined by the independent reading center
* Availability of historical visual acuity (VA) data and spectral-domain optical coherence tomography (SD-OCT). Additionally, fluorescein angiography or color fundus photography can both be used to support participant eligibility per protocol at investigator discretion
* Availability of comprehensive historical anti-vascular endothelial growth factor (VEGF) injection data, including agent administered and date of administration from the time of diagnosis, or for at least 2 years prior to screening if diagnosis was made more than 2 years before screening
* Response to at least two prior anti-VEGF IVT injections as determined by the investigator based on the following:
* Overall decrease in nAMD disease activity detected on historical or screening OCT
* Stable or improved best-corrected visual acuity (BCVA)
* BCVA of 34 letters (approximate 20/200 Snellen equivalent) or better, using Early Treatment of Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters at screening and enrollment
* All subtypes of nAMD lesions are permissible
* nAMD lesions at the time of diagnosis must involve the macula
* Sufficiently clear ocular media and adequate pupillary dilation to allow for clinical examination …
What they're measuring
1
Percent Change in Corneal Endothelial Cell Density (ECD) From Baseline at Week 48 in the Study Eye as Compared With the Fellow Eye, as Assessed by Specular Microscopy
Timeframe: Baseline, Week 48
Trial details
NCT IDNCT04853251
SponsorGenentech, Inc.
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2028-03-31
Contact for this trial
Reference Study ID Number: ML43000 https://forpatients.roche.com/