Aflibercept for Macular Oedema With Underlying Retinitis Pigmentosa (AMOUR) Study

NCT02661711 | Completed Phase 2 Results DMC

• 2 other identifiers: MICM10142015-003723-65
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the safety and efficacy of intravitreal injections of Aflibercept (Eylea) in treating Cystoid Macula Oedema (CMO) in patients with underlying Retinitis Pigmentosa (RP).

Conditions

Macular Oedema; Retinitis Pigmentosa

Keywords

Macular Oedema Retinitis Pigmentosa

Outcome Measures

Primary Outcomes (1)

• Mean Central Macular Thickness (CMT) on Spectral Domain OCT (SDOCT) at 12 Months

  Mean Central Macular Thickness (CMT) on Spectral Domain OCT (SDOCT) at 12 months

  at 12 months

Secondary Outcomes (10)

• The Mean Change in Central Macular Thickness on Spectral Domain Optical Coherence Tomography (SD-OCT) From Baseline to 6 Months and Baseline to 12 Months

  baseline to 6 months and baseline to 12 months

• The Mean Best Corrected Visual Acuity (BCVA) Using the ETDRS Visual Acuity Chart at 6 and 12 Months

  baseline to 6 months and baseline to 12 months

• The Mean Change in ETDRS BCVA at 6 Months and at 12 Months

  at 6 months and at 12 months

• The Mean Macular Volume on SDOCT at 6 and 12 Months

  baseline to 6 months and baseline to 12 months

• The Mean Change in Macular Volume on SDOCT From Baseline to 6 Months and Baseline to 12 Months

  baseline to 6 months and baseline to 12 months

Study Arms (1)

Aflibercept (Eylea)

EXPERIMENTAL

All patients recruited to the study will receive 3 loading intravitreal injections of Aflibercept (Eylea) at monthly intervals followed by a treat and extend protocol up to 12 months. Extension from monthly to 6, 8, 10 and 12 week follow-up will occur when there is evidence of OCT stability in the view of the investigator i.e. there is no further reduction in macular fluid compared to the previous visit. All patients will receive 5 injections before considering them non-responders.

Drug: Aflibercept

Interventions

Aflibercept DRUG

2mg of 40mg/ml of Eylea Solution administered via intravitreal injection every four weeks for three months (loading dose), followed by a treat and extend protocol up to 12 months. Extension from monthly to 6, 8, 10 and 12 week follow up will occur where there is no reduction in macula oedema compared with the previous visit. Number of cycles; minimum of 5 injections and maximum of 13 injections per study eye.

Also known as: Eylea

Aflibercept (Eylea)

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• CMO in association with RP
• \> 16 years of age
• Unilateral or Bilateral CMO (the worse eye only will be treated - defined as the eye with a greater central macular thickness (CMT) on OCT)
• No previous oral treatment for CMO for last 3 months
• No previous peribulbar or intravitreal treatment for CMO in the study eye for last 3 months
• No previous topical treatment for CMO in the study eye for last 1 month
• Central visual impairment that in the view of the Principal Investigator is due to CMO
• BCVA better than 3/60

You may not qualify if:

• Insufficient patient cooperation or media clarity to allow adequate fundus imaging.
• Evidence of visually significant vitreo-retinal traction or epiretinal membrane on OCT that in the Principal Investigator's opinion is highly likely to significantly limit the efficacy of intravitreal therapy.
• History of cataract surgery within prior 3 months or cataract surgery anticipated within 6 months of starting the study.
• Any anti-VEGF treatment to study eye within 3 months.
• History of YAG capsulotomy performed within 3 months.
• Uncontrolled Intraocular pressure (IOP) \> = 24 mmHg for ocular hypertension (on topical IOP lowering medications)
• Advanced glaucoma (in the opinion of a glaucoma specialist).
• Patients with active or suspected ocular or periocular infections
• Patients with active severe intraocular inflammation.
• Patients with a new, untreated retinal tear or detachment
• Patients with a stage 3 or 4 macular hole
• Thromboembolic event (MI/CVA/Unstable Angina) within 6 months.
• Pregnancy or family planned within 15 months
• Females who are breast feeding
• Known allergy or hypersensitivity to anti-VEGF products

Sponsors & Collaborators

• Moorfields Eye Hospital NHS Foundation Trust: lead
• Bayer: collaborator

Study Sites (1)

Moorfields Eye Hospital

London, EC1V 2PD, United Kingdom

Location

Related Publications (1)

• Strong SA, Peto T, Bunce C, Xing W, Georgiou M, Esposti SD, Kalitzeos A, Webster A, Michaelides M. Prospective exploratory study to assess the safety and efficacy of aflibercept in cystoid macular oedema associated with retinitis pigmentosa. Br J Ophthalmol. 2020 Sep;104(9):1203-1208. doi: 10.1136/bjophthalmol-2019-315152. Epub 2020 Feb 10.

  PMID: 32041720 DERIVED

MeSH Terms

Conditions

Macular Edema; Retinitis Pigmentosa

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; Eye Diseases, Hereditary; Retinal Dystrophies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Tumelo Kaminskas
• Organization: Moorfields Eye Hospital

moorfields.resadmin@nhs.net

02072533411

Study Officials

• Michel Michaelides, Professor

  Moorfields Eye Hospital, Institute of Ophthalmology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2016
• First Posted: January 22, 2016
• Study Start: March 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: May 6, 2024
• Results First Posted: May 6, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)