A Study to Evaluate Long-Term Safety and Tolerability of the Port Delivery System with Ranibizumab in Patients with Neovascular Age-Related Macular Degeneration (Portal)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

F. Hoffmann-La Roche AG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Eye Diseases [C11]

Trial duration

16 May 2022 → ongoing

Decision date (initial)

2024-08-19

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

F. Hoffmann-La Roche AG

External identifiers

EU CT number

2023-507131-38-00

EudraCT number

2020-004427-16

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Others, Safety

To evaluate the long-term safety and tolerability of ranibizumab delivered via the Port Delivery System with ranibizumab (PDS) every 24 weeks (Q24W) or every 36 weeks (Q36W) with the 100 mg/mL formulation.

Secondary objectives 3

1. To evaluate the efficacy of ranibizumab delivered via the PDS Q24W or Q36W with the 100 mg/mL formulation, as assessed by visual acuity
2. To evaluate the efficacy of ranibizumab, delivered via the PDS Q24W or Q36W with the 100-mg/mL formulation, as assessed by center point thickness (CPT) on optical coherence tomography (OCT)
3. To evaluate the proportion of patients who undergo supplemental treatment with intravitreal ranibizumab 0.5 mg

Conditions and MedDRA coding

Neovascular Age-Related Macular Degeneration (nAMD)

Regulatory references

Plan to share IPD

No

IPD plan description

N/A

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Previous enrollment in and completion of Study GX28228 (Ladder) or Study GR40548 (Archway), without early treatment or study discontinuation in either study (monthly intravitreal ranibizumab 0.5 mg or implant arms) OR Previous enrollment in Study WR42221 (Velodrome) and either not eligible to be randomized in Study WR42221 at Week 24 or completed the study (from the Q24W or Q36W arm)
2. Ability and willingness to undertake all scheduled visits and assessments
3. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures during the treatment period and for at least 3 months after the last intravitreal injection of ranibizumab or 1 year after the last implant refill-exchange of ranibizumab

Exclusion criteria 4

1. Pregnant or breastfeeding, or intending to become pregnant during the treatment period and for at least 3 months after the final intravitreal injection of ranibizumab or 1 year after the last implant refill-exchange of ranibizumab
2. History of other ocular diseases that give reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab, that might affect interpretation of the results of the study or that renders the patient at high risk for treatment complications
3. History of other diseases, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab or placement of the implant and that might affect interpretation of the results of the study or that renders the patient at high risk of treatment complications
4. Requirement for continuous use of any medications or treatments indicated in the "Prohibited Therapy"

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 5

1. 1. Incidence and severity of ocular and systemic (non-ocular) adverse events
2. 2. Incidence, severity, and duration of adverse event of special interest (AESIs)
3. 3. Incidence, severity, and duration of ocular AESIs during the post operative period (up to 37 days of initial implantation) and follow up period (>37 days after implantation surgery) for patients who receive the implant in the study
4. 4. Incidence and severity of adverse device effects
5. 5. Incidence, causality, severity, and duration of anticipated serious adverse device effects

Secondary endpoints 6

1. 1. Change in best-corrected visual acuity (BCVA) score from baseline over time, as assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart at a starting distance of 4 meters
2. 2. Percentage of patients who lose < 15, < 10, or < 5 letters in BCVA score from baseline over time
3. 3. Percentage of patients with BCVA score of 38 letters (of 20/200 approximate Snellen equivalent) or worse over time
4. 4. Percentage of patients with BCVA score of 69 letters (20/40 approximate Snellen equivalent) or better over time
5. 5. Change from baseline in CPT over time
6. 6. Percentage of patients who undergo supplemental treatment with intravitreal ranibizumab 0.5 mg during each refill-exchange interval

Investigational products

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

Test 2

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

F. Hoffmann-La Roche AG

Sponsor organisation

F. Hoffmann-La Roche AG

Address

Grenzacherstrasse 124

City

Basel

Postcode

4058

Country

Switzerland

Scientific contact point

Organisation

F. Hoffmann-La Roche AG

Contact name

Trial Information Support Line - TISL

Public contact point

Organisation

F. Hoffmann-La Roche AG

Contact name

Trial Information Support Line - TISL

Third parties 13

Locations

6 EU/EEA countries · 61 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

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

Documents 57 files

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

Application history

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