RETINAL CLINICAL TRIALS
RETINAL CLINICAL TRIALS
RETINAL CLINICAL TRIALS
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<strong>RETINAL</strong> <strong>CLINICAL</strong> <strong>TRIALS</strong><br />
<strong>CLINICAL</strong> TRIAL OPTIONS FOR YOUR PATIENTS<br />
SAVE SIGHT INSTITUTE &<br />
SYDNEY EYE HOSPITAL<br />
CONDITION KEY CRITERIA* TRIAL DETAILS STATUS<br />
Diabetic<br />
Macular<br />
Oedema #1<br />
Diabetic<br />
Macular<br />
Oedema #2<br />
Diabetic<br />
Macular<br />
Oedema #3<br />
Diabetes<br />
+/- Diabetic<br />
Retinopathy<br />
RVO<br />
Macular<br />
Telangiectasia<br />
VA 6/12-6/120.<br />
Can enroll OU.<br />
Central thickness >250μm.<br />
Laser unlikely to benefit<br />
VA 6/12 - ~6/90;<br />
Diabetic macular oedema > 300 μm;<br />
Could benefit from laser<br />
3 months since laser or anti-VEGF<br />
medication in study eye<br />
VA ~6/7.5 – 6/60;<br />
Central Retinal Thickness > 350 μm;<br />
Laser unlikely to benefit and at least<br />
3 months since previous laser, steriods<br />
and anti-VEGF<br />
Type I diabetes.<br />
Type II diabetes >5yrs and on<br />
medication<br />
VA 6/12 - ~6/90.<br />
CRVO < 9months or BRVO < 12m<br />
prior to screening w Macular<br />
involvement.<br />
CMT >275μm (Stratus,) >300 (Cirrus,)<br />
or 320μm Spectralis.<br />
MACTEL Patients and their<br />
primary family members<br />
2 yr trial.<br />
Dexamethasone slow<br />
release implant vs<br />
Avastin (1:1)<br />
3 yr trial VEGF Trapeye<br />
(2 dose schedules)<br />
vs laser 2:1<br />
6 months eye drop<br />
(FOV2304) trial;<br />
placebo controlled<br />
Non therapeutic<br />
genetic study. Single<br />
blood draw, eye<br />
exam & history. x1 visit<br />
12m trial. Monthly<br />
visits. Control drug is<br />
Ozurdex.<br />
5 year, natural history<br />
study.<br />
Yearly visits over 5 yrs.<br />
Family members x1<br />
visit<br />
RECRUITING<br />
RECRUITING<br />
RECRUITING<br />
for a<br />
late July 2011<br />
start<br />
RECRUITING<br />
RECRUITING<br />
for a<br />
late July 2011<br />
start<br />
RECRUITING<br />
* Expanded criteria on reverse<br />
More Details, Patient Information Sheets, Consent Forms &<br />
All Research Clinic Appointments<br />
Updated<br />
19/7/11<br />
V7.3<br />
PLEASE CALL Study Coordinators: 02 9382 7309 Mob 0412 338 075<br />
sydney.edu.au/medicine/mac<br />
retina@eye.usyd.edu.au<br />
Principal Investigators: Prof Mark Gillies Mob 0412 060 313<br />
A/Prof Samantha Fraser-Bell 02 9382 7309
EXPANDED IINCLUSIION/EXCLUSIION CRIITERIIA<br />
Diabetic Macular Oedema #1<br />
INCLUSION<br />
- DMO affecting fovea in one or both eyes where laser Rx is<br />
unlikely to benefit<br />
- VA 6/12-6/120<br />
- Retinal thickness >250 μm on OCT<br />
EXLCUSION<br />
- Uncontrolled glaucoma, or controlled glaucoma on >1<br />
medication<br />
- MO or vision loss due to other causes<br />
- IVTA within 6 months. Peribulbar TA within 3 months<br />
- Retinal laser within 3 months<br />
- Systemic steroid Rx equiv >5mg prednisone/day<br />
- BP >180/110<br />
Diabetic Macular Oedema #2<br />
INCLUSION – DMO (Type I or II diabetes)<br />
-VA 6/12-6/90 study eye<br />
- Central thickness Cirrus OCT ≥300μm<br />
-could benefit from laser<br />
EXCLUSION – Laser or Anti-VEGF injections 3 months prior to<br />
study, Cataract or other ocular surgery 12%,BP >160 or >95 mmHg, CVA or MI last 6 months<br />
->2 macular laser treatments in study eye<br />
-IOP> 25mmHg study eye<br />
Diabetic Retinopathy<br />
INCLUSION: >18yo. Type 1 diabetes. Type 2 diabetes >5yrs & on<br />
meds<br />
RVO<br />
INCLUSION<br />
- ≥ 18yo<br />
- Presence of macular edema due to non-ischemic BRVO or<br />
CRVO with onset < 9m in CRVO or 275μm (Stratus,) >300 (Cirrus,) >320 (Spectralis)<br />
EXCLUSION<br />
- Retinal Laser within 3months<br />
- Cataract or Lasik Sx within last 3months or expected<br />
during trial.<br />
- Intravitreal injectable drug other than corticosteroids<br />
within 2months<br />
- Ocular Hypertension (IOP >21mmHg) of Hx of Glaucoma<br />
Macular Telangiectasia<br />
INCLUSION: - ≥18 yo MacTel Type 2<br />
Diabetic Macular Oedema #3<br />
INCLUSION – DMO (Type I or II diabetes)<br />
-VA ~6/7.5-6/60 study eye<br />
- Central thickness Cirrus OCT ≥350μm<br />
-could NOT benefit from laser (or pt refuses)<br />
EXCLUSION – Laser, steroids or Anti-VEGF injections 3 months<br />
prior to study, Cataract or other ocular surgery < 90 days,<br />
panretinal photocoagulation < 4 month ,<br />
-pars planar vitrectomy ,active PDR , vitreomacular traction, or<br />
condition in study eye which could contribute to macular oedema<br />
- HBA1c >10%,BP >160 or >90 mmHg, CNV<br />
-> 1 med for glaucoma<br />
-IOP> 25mmHg study eye<br />
Studies in the Clinical Trial Pipeline:<br />
1. Dry AMD<br />
2. DME/DMO Oral<br />
3. BRVO/CRVO<br />
4. Wet AMD
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