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A Study Assessing Corneal Endothelial Cells in Participants With Neovascular Age-related Macular Degeneration (nAMD) Treated With the Port Delivery System With Ranibizumab (PDS)

ConditionNeovascular Age-related Macular Degeneration
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age50+
SponsorGenentech, Inc.

About this trial

This study will assess corneal endothelial cells in participants with nAMD treated with PDS refilled every 24 weeks (Q24W).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Prior treatment with external-beam radiation therapy or transpupillary thermotherapy

Previous treatment with verteporfin injection (PDT) or corticosteroid IVT injection within 2 years of screening

Previous laser (except PDT as stated above) used for age related macular degeneration (AMD) treatment

History of corneal transplant

Trial design

Design model

Single group

Treatments tested in this trial

  • PDS Implant With Ranibizumab 100 mg/ml

    Device

    Ranibizumab 100 mg/mL will be delivered via PDS

  • LUCENTIS (Ranibizumab Injection)

    Drug

    Ranibizumab (0.5 mg intravitreal \[IVT\] injections of 10 mg/mL formulation) will be used in the study eye as supplemental treatment. If a participant discontinues study treatment, he/she may start receiving IVT ranibizumab injections in the study eye, per investigator's discretion.

Treatment groups

188 Participants
are divided into 1 treatment group
Group A: SUSVIMOExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

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

Time frame
Baseline, Week 48

Secondary outcomes

1

Percent Change in Corneal ECD From Baseline at Week 24 in the Study Eye as Compared With the Fellow Eye

Time frame
Baseline, Week 24
2

Percent Change in the Coefficient of Variation (CV) of Corneal Endothelial Cell Area From Baseline at Weeks 24 and 48 in the Study Eye as Compared With the Fellow Eye

Time frame
Baseline, Week 24, Week 48
3

Percent Change in Hexagonal Cells (HEX) From Baseline at Weeks 24 and 48 in the Study Eye as Compared With the Fellow Eye

Time frame
Baseline, Week 24, Week 48
4

Percentage of Participants With Ocular Serious Adverse Events (SAEs) and Severity of SAEs

Time frame
Day 1 up to approximately Week 52

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Genentech, Inc.

Lead sponsor

Source ClinicalTrials.gov
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