Spontaneous Retinal Arterial Pulsations (SRAPs) as a Prognostic Determinant of Central Retinal Vein Occlusions (CRVOs) in patients treated or not with intravitreal injections of aflibercept

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fondation A De Rothschild

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Eye Diseases [C11]

Trial duration

24 Mar 2021 → 17 Mar 2025

Decision date (initial)

2024-11-12

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Bayer Healthcare

External identifiers

EU CT number

2024-516681-10-01

EudraCT number

2020-005449-18

ClinicalTrials.gov

NCT04793100

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

To compare the evolution of visual acuity between inclusion and the one-year visit in CRVO patients with PARS versus those without PARS.

Secondary objectives 5

1. Comparison of percentages of PARS+ and PARS- patients at inclusion who developed macular edema during the first year of follow-up
2. Comparison between PARS+ and PARS- patients at inclusion of changes in macular thickness between diagnosis and 1-year visit;
3. Comparison between PARS+ and PARS- patients at inclusion of percentages of occurrence of CRVO-related complications during the first year of follow-up (neovascular glaucoma or intravitreal hemorrhage)
4. Comparison between PARS+ and PARS- patients at inclusion of mean time between last 2 aflibercept injections (only for patients treated with aflibercept)
5. Comparison between PARS+ and PARS- patients at inclusion of mean time between last 2 aflibercept injections (only for patients treated with aflibercept).

Conditions and MedDRA coding

central retinal vein occlusions

Study design 1 period

Regulatory references

Plan to share IPD

No

IPD plan description

NA

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Patient over 18
2. Diagnosis of CRVO (central retinal vein occlusion), with or without macular edema.
3. Naïve to intravitreal injection and intravitreal corticosteroid implant
4. Member or beneficiary of a health insurance scheme
5. Having received informed information about the study and having signed a consent form to participate in the study
6. For women of childbearing age: commitment to effective contraception during aflibercept treatment and for at least 3 months after the last intravitreal injection of aflibercept
7. Onset of symptoms in previous month (maximum 30 days prior to inclusion)

Exclusion criteria 14

1. Patient under legal protection
2. Severe intraocular inflammation
3. Hypersensitivity to EYLEA® : to the active substance (aflibercept) or to one of the excipients
4. Pregnant or breast-feeding women
5. Previous stroke or myocardial infarction within the last 3 months
6. Untreated retinal detachment or dehiscence
7. Ocular media opacities
8. Amblyopia
9. Diabetic retinopathy
10. Macular edema of etiology other than CRVO (central retinal vein occlusion)
11. Active or suspected ocular or periocular infection
12. Secondary exclusion criteria: ocular media opacities
13. Secondary exclusion criteria: diabetic retinopathy
14. Secondary exclusion criteria: administration of a drug other than aflibercept during the study

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change in visual acuity (BCVA on ETDRS scale) in letters read and validated between the start of treatment and 1 year.

Secondary endpoints 5

1. Macular edema will be determined by the ophthalmologist from the OCT examination
2. Measurement of macular thickness in μm is performed using OCT-integrated measurement software
3. CRVO complications will be collected at one year from the patient's record
4. The number of aflibercept injections during the first year of follow-up will be collected at one year from the patient's record
5. The time between the last 2 injections of aflibercept will be collected at one year from the patient's file

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fondation A De Rothschild

Sponsor organisation

Fondation A De Rothschild

Address

29 Rue Manin

City

Paris

Postcode

75019

Country

France

Scientific contact point

Organisation

Fondation A De Rothschild

Contact name

Clinical research Department

Public contact point

Organisation

Fondation A De Rothschild

Contact name

Clinical research Department

Locations

1 EU/EEA country · 3 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

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 7 files

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

Application history

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