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Rapid Avastin (Bevacizumab) treatment and extension in low-risk age-related macular degeneration patients.

Palmerston North Interventional Rapid Avastin Treat & Extend (PIRATE) study in low-risk age-related macular degeneration patients.

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622001246774
Acronym
PIRATE
Enrollment
100
Registered
2022-09-15
Start date
2022-10-01
Completion date
Unknown
Last updated
2022-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Age-related macular degeneration (AMD) is the primary cause of blindness of individuals over the age of 50 years in New Zealand. It is a lifelong chronic ocular condition requiring monitoring and treatment to prevent progression and irreversible visual loss. The prevalence of AMD is projected to increase by 20-40% over the next 10 years as a direct result of New Zealand’s aging population. With the current standardised treat and extend protocol (TAE), nAMD patients receive a loading dose of 3 Bevacizumab (Avastin) injections 4 weeks apart. The injection interval is then adjusted according to the level of disease activity. Patients with stable disease are extended by 2-week increments. For example; a patient receiving an Avastin injection every 4 weeks with stable disease activity would be subsequently extended to a 6-week injection interval. This would then be reassessed at the end of the 6-week treatment period to determine if it can be extended further to 8 weeks or requires to be reduced back to 4 weeks based on their disease activity (fluid-free status). Increment adjustments therefore only occurring at 2-week intervals. Injection frequency not only affects patients’ treatment burden but also leads to increasing demand on all aspects of ophthalmology service provision including; nurse-led injectors, macular review / hybrid clinic nurses, ophthalmology registrars and overseeing ophthalmologists. There are further constraints on physical space to perform injections and additional administrational work that accompanies intravitreal injection scheduling. Current practicing standards are unlikely to meet the projected increasing demand of nAMD patients expected over the next 10 years and therefore new innovative changes are required to current service provision. In the Palmerston North Interventional Rapid Avastin Treat & Extend (PIRATE) study we propose to investigate a modified treat and extend protocol. In the modified protocol, treatment adjustments would be in 4-week increments in patients with a low-risk nAMD. As an additional safety feature, any patient who require interval shortening or experience any adverse event from rapid treatment extension will have their interval immediately shortened by 4 weeks, with subsequent extension as per the current standard 2-week protocol. Each eligible patient will be informed of participation in the trial and may further opt-out of 4-week adjustments at any point if they so choose. Through this trial we hope to provide evidence to support rapid treatment extension of nAMD as a safe, efficient and practical method to adapt to our aging population and associated ophthalmic service constraints.

Interventions

In the PIRATE study we propose to investigate a modified treat and extend protocol. We will investigate extending treatment intervals by 4-weeks (treatment group) compared to the standard protocol of 2-weeks (control group). Study population: Individuals with low-risk neovascular age-related macular generation (nAMD) (please see study protocol attached for specific low/high-risk stratification of nAMD). Therapeutics: All participants will receive 0.05mL Bevacizumab (Avastin) 3.75mg/0.15mL ad

In the PIRATE study we propose to investigate a modified treat and extend protocol. We will investigate extending treatment intervals by 4-weeks (treatment group) compared to the standard protocol of 2-weeks (control group). Study population: Individuals with low-risk neovascular age-related macular generation (nAMD) (please see study protocol attached for specific low/high-risk stratification of nAMD). Therapeutics: All participants will receive 0.05mL Bevacizumab (Avastin) 3.75mg/0.15mL administered as an intravitreal injection into the vitreous cavity of effected eye. These will be administered either by a qualified nurse injector or ophthalmology registrar/consultant. Treatment frequency (treatment group): 3x Avastin at monthly intervals (induction), then treatment extension by 4 weeks if extension criteria meet (e.g. 8 weeks, 12 weeks, 16 weeks) until 16 weeks post-induction is reached (maximum treatment interval). If shortening criteria meet, then shortened by 4 weeks with each subsequent extensions will be at 2 weeks (as per standard protocol). Treatment monitoring: each injection will be provided around a clinic appointment with optical coherence tomography (OCT) + clinical assessment. This will allow monitoring of treatment response or related adverse-effect. Strict shortening/extension/maintenance criteria has been established (please see study protocol attached for outlined criteria). The term “rapid” corresponds to the treatment group’s 4-week treatment extension. Participants in this group will reach the 16 weeks maximal treatment interval in a minimum of 6 injections. The standard protocol (control group) in comparison takes a minimum of 9 injections. The treatment group has therefore a more “rapid” treatment extension as it requires fewer injections and therefore reaches the 16 weeks maximal extension "faster".

Sponsors

Palmerston North Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No

Inclusion criteria

•Patients greater than or equal to 50 years of age •Low-risk nvAMD characteristics (see risk-stratification outlined below) with likely subfoveal or juxtafoveal choroidal neovascular membrane (CNVM). These being diagnosed clinically, confirmed by investigator (ophthalmology registrar or ophthalmologist) •Deemed appropriate for Avastin therapy by investigator •Best corrected visual acuity (BCVA) between 6/12 - 6/180 at first visit in study eye •If both eyes affected then the eye with the worse BCVA will be included in the trial as the study eye •Participants must be willing and able to provide independent informed consent Participants with be stratified based on their nAMD characteristics. High-risk participants will be deemed anyone who meets one or more of the following criteria: 1. Monocular patients (i.e. only have a single good-seeing eye) 2. Macular haemorrhage (greater or equal to 1 disc diameter) clinically or on fundus photo 3. History of previous of large macular haemorrhage 4. Subretinal fluids (SRF) less than 200 microns 5. Recent reduction of injection frequency for any reason (i.e. if shortened by 4 weeks, then further extensions will be at 2 week intervals or ‘usual treatment’ as in control group) High-risk participants will NOT be included in the PIRATE study cohort. They will continue with the current standard anti-VEGF therapy. Low-risk participants will be deemed anyone who meets the inclusion criteria WITHOUT having any of the high-risk criteria outlined.

Exclusion criteria

•Prior treatment of the study eye with intraocular anti-VEGF agents, verteporfin photodynamic therapy, other laser treatment, intraocular corticosteroids, surgical procedures (except cataract surgery greater than or equal to 30 days prior to screening) •Systemic use of anti-VEGF agents within 3 months prior to the study entry period •Active or suspected infection in or surrounding the study eye •Peripapillary CNVM •Active severe intraocular inflammation in the study eye •Intraocular pressure greater than 28mmHg in study eye •Ocular condition that might impact vision and confound study outcomes in the study eye (by the discretion of ophthalmology registrar or ophthalmologist) •History of Avastin allergy or related intravitreal administration agents (e.g. povidone iodine, lidocaine, gutt. Iopidine, gutt. Chloramphenicol) •Women who are pregnant, suspected to be pregnant or lactating •Previous or concomitant participation in another clinical study with investigational medicinal product(s) within last 3 months •Individuals who lack decision-making capacity who are not able to provide independent informed consent for the trial •Any other patient deemed ineligible by investigator (ophthalmology registrar or ophthalmologist)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 10, 2026