Long-term Follow-Up Study of RGX-314 and Fellow Eye Substudy

Overview

Sponsor-declared trial summary

Key facts

Sponsor

AbbVie Deutschland GmbH & Co. KG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Eye Diseases [C11]

Decision date (initial)

2025-07-16

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

AbbVie Inc.

External identifiers

EU CT number

2023-505750-17-00

ClinicalTrials.gov

NCT03999801

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To evaluate the long-term safety of ABBV-RGX-314

Secondary objectives 5

1. To evaluate the long-term safety of ABBV-RGX-314
2. To evaluate the persistence of effect of ABBV-RGX-314 on best-corrected visual acuity (BCVA)
3. To evaluate the persistence of effect of ABBV-RGX-314 on central retinal thickness (CRT) as measured by spectral domain-optical coherence tomography (SD-OCT)
4. To assess the need for supplemental anti-vascular endothelial growth factor (VEGF) therapy
5. To assess the need of clinic visits for neovascular age-related macular degeneration disease management

Conditions and MedDRA coding

Neovascular age-related macular degeneration

Regulatory references

Scientific advice from competent authorities

Japan Pharmaceutical Manufacturers Association, European Medicines Agency, Food And Drug Administration

Plan to share IPD

Yes

IPD plan description

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information. To learn more about the process, or to submit a request, visit https://www.abbvieclinicaltrials.com/hcp/data-sharing/ For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Able and willing to provide written, signed informed consent for this study
2. Previously enrolled in a clinical study of ABBV-RGX-314 subretinal administration for the treatment of nAMD and must have received treatment in that study
3. Must be willing and able to comply with all study procedures

Exclusion criteria 1

1. Not Applicable

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Incidence of ocular adverse events (AEs) and any serious adverse events (SAEs)

Secondary endpoints 10

1. Incidence of non-ocular AEs and any adverse events of special interest (AESIs)
2. Mean change from baseline (ie, prior to ABBV-RGX-314 administration in the parent study) in BCVA
3. Proportion of participants losing letters in BCVA compared with baseline (ie, prior to ABBV-RGX 314 administration in the parent study) in the study eye at assessed timepoints
4. Mean change from baseline (ie, prior to ABBV-RGX-314 administration in the parent study) in CRT as measured by SD-OCT in the study eye at assessed timepoints
5. Mean supplemental anti-VEGF injection annualized rate through years 2, 3, 4, and 5 based on ongoing chart review in the study eye
6. Mean supplemental anti-VEGF injection annualized rate in years 2, 3, 4, and 5 based on ongoing chart review in the study eye
7. Mean number of supplemental anti-VEGF injections through years 2, 3, 4, and 5 based on ongoing chart review in the study eye
8. Mean number of supplemental anti-VEGF injections in years 2, 3, 4, and 5 based on ongoing chart review in the study eye
9. Mean number of retina specialist visits attended for nAMD through years 2, 3, 4, and 5 based on ongoing chart review
10. Mean number of retina specialist visits attended for nAMD in years 2, 3, 4, and 5 based on ongoing chart review

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AbbVie Deutschland GmbH & Co. KG

Sponsor organisation

AbbVie Deutschland GmbH & Co. KG

Address

Knollstrasse

City

Ludwigshafen Am Rhein

Postcode

67061

Country

Germany

Scientific contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinical Trials Helpdesk

Public contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinical Trials Helpdesk

Third parties 6

Locations

5 EU/EEA countries · 39 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 36 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications