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Our research trials

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CERA is currently conducting a number of clinical trials in the following areas:

  1. Age-related-macular degeneration
  2. Diabetic Retinopathy
  3. Other retinal conditions
  4. Glaucoma
  5. Uveitis

1. Age-related Macular Degeneration

FILLY (for Geographic Atrophy)

Status: Recruiting

A Phase II, Multicentre, Randomised, Single-Masked, Sham-Controlled Study of Safety, Tolerability and Evidence of Activity of Intravitreal APL-2 Therapy in Patients with Geographic Atrophy (GA)

Principal investigator: Professor Robyn Guymer

Main inclusion criteria

  1. If GA is multifocal, at least one focal lesion ≥ 1.25mm2
  2. The total lesion area ≥ 2.5 and ≤ 17.5mm2
  3. GA can be completely visualized on the macula centered image
  4. GA must be able to be photographed in its entirety
  5. GA must be able to be measured separately from any areas of PPA
  6. Presence of banded, patchy or diffuse patterns of hyperautofluorescence in the junctional zone of GA
  7. BCVA ≥ 6/95

Exclusion criteria

  1. History or evidence of CNV in the study eye
  2. Absence of hyperautofluorescence or presence of focal pattern of hyperautofluorescence adjacent to the area of GA
  3. GA due to causes other than AMD
  4. -6 diopters of myopia or worse

PROXIMA A – (Natural History Geographic Atrophy Study)

Status: Recruiting

The primary objective of the study is to generate a better understanding of the variability and dynamic range of visual function tests over time and how these changes correlate with changes in Geographic Atrophy area in patients with Geographic Atrophy (GA) secondary to Aged related Macular Degeneration (AMD).

 Principal investigator: Professor Robyn Guymer

Visit information:

The study includes 10 visits over 48 months (4 years) with one approximately 2 hour appointment every 6 months.

Main inclusion criteria

  1. Age ≥ 50 years
  2. Best–corrected visual acuity of 6/30 or better in study eye
  3. Bilateral Geographic Atrophy secondary to AMD with no prior evidence of CNV
    • Total GA size lesion between 1-7 disc areas
    • Presence of hyperfluorescence of either banded or diffuse pattern adjacent to the area of GA

Main exclusion criteria

  1. Active CNV in either eye
  2. GA in either eye due to causes other that AMD
  3. RPE tear that involves the macular
  4. Previous subthreshold or photocoagulation laser
  5. -8 Diopters or more of Myopia

PROXIMA B – (Natural History Geographic Atrophy Study)

Status: Recruiting

The primary objective of the study is to generate a better understanding of the variability and dynamic range of visual function tests over time and how these changes correlate with changes in Geographic Atrophy area in patients with Geographic Atrophy (GA) secondary to Aged related Macular Degeneration (AMD).

Principal investigator: Professor Robyn Guymer

Visit information:

The study includes 12 visits over 68 months (5 years) with one approximately 2 hour appointment every 6 months.

Main inclusion criteria

  1. Age ≥ 50 years
  2. Best–corrected visual acuity of 6/120 or better in study eye
  3. GA secondary to AMD in study eye
    • Total GA size lesion between 0.5-7 disc areas
    • Presence of hyperfluorescence of either banded or diffuse pattern adjacent to the area of GA
  4. Non study
    1. Cohort 1: no evidence of GA or CNV (unilateral GA)
    2. Cohort 2: prior or active CNV (with or without co-existing GA)

Main exclusion criteria

  1. GA in either eye due to causes other that AMD
  2. RPE tear that involves the macular
  3. Previous subthreshold or photocoagulation laser
  4. -8 Diopters or more of Myopia
  5. History of vitrectomy, sub macular surgery or any surgical intervention for AMD

Lampalizumab (for Geographic Atrophy)

Status: Recruiting

Phase III, Multi-center, Randomized, Double-Masked, Sham-Controlled Study of Efficacy and Safety of Lampalizumab ITV Injections Administered Monthly for 24 Months in Patients with Geographic Atrophy Secondary to AMD.

Principal investigator: Professor Robyn Guymer

Key inclusion criteria:

  1. Bilateral GA
  2. BCVA of 6/7.5 to 6/30
  3. GA must be ≥ 1 DA (2.5mm2) in the absence of CNV
  4. If GA is multifocal, at least one focal lesion must be ≥ 0.5 DA (1.25 mm2)
  5. Total lesion size must be ≤ 7 DA (17.5mm2) and must reside completely within the FAF imaging field
  6. Presence of hyperautoflourescence of either banded or diffuse pattern adjacent to the area of GA

Key Exclusion criteria:

  1. Active CNV in either eye
  2.  RPE tear involving the macula in the study eye
  3. Concurrent ocular or intraocular condition in the study eye (e.g., cataract or diabetic retinopathy)
  4. Active uveitis and/or vitritis (grade trace or above) in either eye
  5. – 8 dioptres of myopia or more

Beacon (for Geographic Atrophy)

Status: Recruiting

A phase 2b study to assess the safety and efficacy of a Posterior Segment Drug Delivery System (DDS) with Brimonidine in patients with geographic atrophy GA.

Principal investigator: Professor Robyn Guymer

Main inclusion criteria

  1. Multifocal lesions located outside a 300μm radius the fovea
  2. At least one focal lesion ≥ 0.3 mm2
  3. The total lesion area 1.25mm2 – 12.5mm2
  4. Lesions must occupy ≤ 50% of the area between a 0.5 mm radius and a 1.5mm radius from the foveal center point
  5. Banded or diffuse perilesional hyper-auto fluorescence evident on auto fluorescence
  6. The distance between the optic disc or PPA and any atrophic lesion must be >500μm
  7. Presence of ≥ 5 reticular drusen
  8. BCVA ≥ 6/19
  9. Fellow eye BCVA 6/60 or better

Exclusion criteria

  1. History or evidence of CNV in either eye
  2. Diagnosis of central GA
  3. -6 diopters of myopia or worse
  4. Diabetic retinopathy

Fovista for Treatment of Naïve Age-Related Macular Degeneration

Status: Recruiting

A phase III randomized, double-masked, controlled trial to establish the safety and efficacy of intravitreous administration of Fovista (anti-PDGF-B pegylated aptamer) administered in combination with Lucentis compared to Lucentis monotherapy in subjects with subfoveal neovascular age-related macular degeneration.

Principal investigator: Dr Sanj Wickremasinghe

Key Inclusion criteria:

  1. Subfoveal CNV due to AMD with some classic component
  2. BCVA between 6/18 and 6/60 inclusive
  3. Total lesion size ≤ 5 Disc Areas (at least 50% active CNV)
  4. Presence on OCT of subretinal, intraretinal or sub-RPE fluid and/or subretinal thickening/reflectivity consistent with active CNV
  5. Clear ocular media to allow sufficient fundus photo and FA quality
  6. IOP ≤ 21mmHg

Key Exclusion criteria:

  1. Prior treatment in the study eye
  2. More than 25% of total lesion size made up of scarring or atrophy.
  3. More than 50% of total lesion size consisting of subretinal haemorrhage
  4. Presence of Retinal Angiomatous Proliferation (RAP)
  5. Presence of significant PED
  6. Diabetes Mellitus
  7. History or evidence of severe cardiac disease
  8. Stroke within 12 months
  9. Major surgical procedure within 1 month

The following studies have closed for recruitment and are in the follow up stages:

Fluid Wet AMD Trial

A Phase IV, randomised, controlled study investigating the efficacy and safety of ranibizumab “inject and extend” using an intensive retinal fluid retreatment regimen compared to a relaxed retinal fluid retreatment regimen in patients with wet- age related macular degeneration (AMD).

Principal Investigator: Dr Sanj Wickresmasinghe

Planet (for Polypoidal choroidal vasculopathy)

A randomized, double-masked, sham-controlled phase 3b/4 study of the efficacy, safety, and tolerability of intravitreal Aflibercept monotherapy compared to Aflibercept with adjunctive photodynamic therapy as indicated in subjects with polypoidal choroidal vasculopathy (PCV).

Principal investigator: Dr Sanj Wickresmasinghe

Laser intervention in Early Age-related Macular Degeneration study (LEAD)

Age-related macular degeneration has a relatively slow progression rate from the early to the late stages of the disease. Therefore there is a large window of opportunity to treat patients in the early stages of AMD before any visual impairment has occurred. The LEAD study aims to provide an early intervention using the 2RT nanosecond laser, which may slow or partially reverse the progression of the disease, before any late changes develop.

Principal investigator: Professor Robyn Guymer

2. Diabetic Retinopathy

We are not currently recruiting for any studies on diabetic retinopathy. We are in the follow-up stage of the following studies:

DiMECat

A Randomised, single-masked, controlled trial of intravitreal Avastin (bevacizumab) vs. Triesence (triamcinolone) at the time of cataract surgery for patients with diabetic macular oedema.

Principal Investigator: Dr Lyndell Lim

SwitchDMO

A multicentre clinical trial of switching between intravitreal bevacizumab (Avastin®) and intravitreal dexamethasone (Ozurdex™) for persistent DME (SwitchDMO).

Principal Investigator: Dr Lyndell Lim

CONTROL DME

An open-label, multi-centre, 24-month study to evaluate the comparative efficacy of Lucentis (ranibizumab) 0.5mg intravitreal injection in patients with DME with well controlled and poorly controlled diabetes mellitus.

Principal Investigator: Dr Lyndell Lim

Bevordex DME

A multicentre randomised clinical trial of intravitreal bevacizumab (Avastin®) versus intravitreal dexamethasone (Ozurdex™) for advanced DME.

Principal Investigator: Dr Sanj Wickremasinghe

VIVID DME

A randomized, double-masked, active-controlled phase III study of the efficacy and safety of repeated doses of intravitreal VEGF Trap-Eye in subjects with DME

Principal Investigator: Dr Lyndell Lim

3. Other retinal conditions

We are not currently recruiting for any studies of other retinal conditions. We are in the follow-up stage of the following studies:

SAVIOR

Study of anti-VEGF in Ocular Rebleeding.

Principal Investigator: Dr Jonathan Yeoh

Brighter BRVO

Principal Investigator: Dr Sanj Wickremasinghe

A 24-month, phase IIIb, open-label, randomized, active-controlled, 3 arm, multicentre study assessing the efficacy and safety of an individualised, stabilisation criteria-driven PRN dosing regimen with 0.5 mg ranibizumab intravitreal injections applied as monotherapy or with adjunctive laser photocoagulation in comparison to laser photocoagulation in patients with visual impairment due to macular oedema secondary to branch retinal vein occlusion (BRVO).

Crystal CRVO

Principal Investigator: Dr Sanj Wickremasinghe

A 24-month, phase IIIb, open-label, single arm, multicenter study assessing the efficacy and safety of an individualized, stabilisation criteria-driven PRN dosing regimen with 0.5 mg ranibizumab intravitreal injections applied as monotherapy in patients with visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO).

4. Glaucoma

We are not currently recruiting for any studies in glaucoma. We are in the follow-up stage of the following study:

Glaucoma Initial Treatment Study (GITS)

Comparing the Effectiveness of Selective Laser Trabeculoplasty with Topical Medication: A Multicentre, prospective, randomised controlled clinical trial.

Principal Investigator: Associate Professor Ecosse Lamoureux

5. Uveitis

Status: Recruiting

First-line Antimetabolites as Steroid-sparing Treatment (FAST) Uveitis Trial

Principal Investigator: Dr Lyndell Lim

In the FAST Uveitis Trial, we propose to establish which immunosuppressive therapy, methotrexate or mycophenolate mofetil, is more effective as a first-line, corticosteroid-sparing agent for the treatment of non-infectious uveitis.

Inclusion

  1. History of non-infectious intermediate, anterior and intermediate, posterior or panuveitis in at least one eye
  2. Active inflammation within the last 90 days
  3. Aged 16 years or older
  4. At least one of the following:
    • Active inflammation after 4 weeks of high dose corticosteroid treatment (1mg/kg prednisone
    • Treatment with oral corticosteroids resulting in a reduction of inflammation, followed by an increase in inflammation when corticosteroid is tapered, in the 14 days prior to enrollment.
    • Known chronic condition necessitating corticosteroid-sparing immunosuppressive treatment
  5. At least 1+ anterior chamber cells and/or 1+ vitreous haze and/or active retinal/choroidal lesions (bullous serous retinal detachment qualifies) in at least one eye at enrollment
  6. Willingness to abstain from alcohol (2 drinks per month is okay)

Exclusion

  1. Any infectious cause of uveitis
  2. Media opacity and/or extensive posterior synechiae such that examination of the posterior segment is not possible in both eyes
  3. Chronic hypotony (IOP < 5 mm Hg for > 3 months) in both eyes
  4. Prior use of any immunosuppressive drug other than prednisone
  5. Periocular or intravitreal corticosteroid injection in the past 90 days
  6. Fluocinolone acetonide implant in either eye in < 3 years
  7. Intraocular surgery in < 30 days, or planning on getting surgery within the next 6 months
  8. BCVA of hand motions or worse in better eye
  9. Systemic autoimmune disease or ocular condition (besides uveitis) anticipated to dictate treatment course

Humira (Adalimumab) for Uveitis Studies

Status: Recruiting

For active uveitis: A multicentre study of the efficacy and safety of the human anti-TNF monoclonal antibody adalimumab as maintenance therapy in subjects requiring high dose.

For inactive uveitis: A multicentre study of the efficacy and safety of the human anti-TNF monoclonal antibody adalimumab as maintenance therapy in subjects with inactive non-infectious intermediate-, posterior or pan-uveitis.

Corticosteroids for active non-infectious intermediate-, posterior-, or pan-uveitis.

Principal Investigator: Dr Lyndell Lim

We are also participating in the following studies that have closed for recruitment:

The EYEGUARD C study

For inactive uveitis: A randomized, double-masked, placebo-controlled study of the safety and efficacy of gevokizumab in the treatment of subjects with non-infectious intermediate, posterior, or pan-uveitis currently controlled with systemic treatment.

Principal Investigator: Dr Lyndell Lim

The EYEGUARD A study

For active uveitis: A randomized, double-masked, placebo-controlled study of the safety and efficacy of gevokizumab in the treatment of active non-infectious intermediate, posterior, or pan-uveitis.

Principal Investigator: Dr Lyndell Lim

We are also participating in the following studies:

MUST Trial

Long-term follow-up of patients who participated in the multicenter uveitis steroid treatment trial.

Principal Investigator: Dr Richard Stawell