Ongoing Studies:

PEDIG ~ Residual Amblyopia Treatment Study (A11)

CNV Secondary to AMD Treated with Beta Radiation Epiretinal Therapy – NeoVista Inc. (CABERNET)

Allergan - A 6 Month, Single Masked, Multicenter, Randomized, Controlled Study(POSURDEX)

Regeneron:  A Randomized, Double Masked, Active Controlled Phase III Study of the Efficacy, Safety, and Tolerability of Repeated Doses of Intravitreal VEGF Trap in Subjects with Neovascular Age-Related Macular Degeneration (VGFT-OD-0605)

Topcon:  Reproducibility of Topcon SC-OCT and Comparison to Stratus TD-OCT

Comparison of AMD Treatment Trials (CATT)  Lucentis – Avastin Trial

A Natural History Study of Macular Telangiectasia The Mactel Study– MACTEL

Age-Related Eye Disease Study 2 - AREDS 2

BRAINPORT

Diabetic Retinopathy Clinical Research Network (DRCR)

Diabetic Retinopathy Clinical Research Network (Study#1A)

SCORE Trial

 

PEDIG ~ Residual Amblyopia Treatment Study (A11)

A Randomized Trial to Evaluate 8 Hours of Daily Patching Plus Daily Atropine for Residual Amblyopia in Children 3 to <8 Years Old

Primary Investigator: Yasmin Bradfield, MD

Study Coordinator: Barb Soderling, Kris Dietzman

Primary Objective:  This study is designed to evaluate the effectiveness of treatment of residual amblyopia in children ages 3 to <8 years with visual acuity of 20/32 to 20/50 in the amblyopic eye.  The study is a randomized clinical trial comparing intensive treatment (8 hours of daily patching plus daily atropine) with a control group that will have rapid weaning of existing treatment followed by spectacle correction only (if needed).  The primary objective is to determine if intensive treatment will improve visual acuity in patients with residual amblyopia. 

Treatment Groups:  Patients will be randomized to one of two treatment regimens:

• Intensive treatment: 8 hours of daily patching combined with daily atropine (1%)
• Control group:  Weaning of the current treatment (two hours of daily patching for patients currently using patching and once weekly atropine for patients currently using atropine) for 4 weeks, then no treatment other than spectacles (if needed). 

Contact and Visit Schedule: 

• Phone call at 4 weeks
• Primary outcome visit at 10 weeks
• If amblyopic eye acuity improved by ≥1 line at primary outcome, follow-up visits at 10 week intervals until no further improvement (≥1 line), confirmed by a re-test

For more information contact Barbara Soderling at 263-7168 or Kris Dietzman at 263-9035

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CNV Secondary to AMD Treated with Beta Radiation Epiretinal Therapy – NeoVista Inc. (CABERNET)

NV1-114 Randomized , Prospective, Controlled Study of the NeoVista System for the Treatment of Subfoveal Choroidal Neovascularization Associated with Wet AMD

Principal Investigator:  Michael Ip, MD

Study Coordinators:  Kris Dietzman and Guy Somers

Primary Objective:  The objective of the CABERNET Trial is to evaluate the safety and efficacy of focal delivery of radiation for the treatment of subfoveal choroidal neovascularization (CNV) associated with wet age-related macular degeneration (AMD). 

Study Design:  The CABERNET Trial is a randomized, prospective, controlled, study of the Epi-Rad90 TM Ophthalmic System for the treatment of subfoveal choroidal neovascularization associated with wet age-related macular degeneration. 

Efficacy Endpoints

Primary:  Primary Efficacy endpoint is non-inferiority of the Epi-Rad 90 TM Ophthalmic System against an active control (Lucentis) with regard to the proportion of subjects losing fewer than 15 letters of best corrected visual acuity score at 12 months compared to baseline, with a non-inferiority margin of 20%. 

Secondary:  1. Percentage of subjects gaining ≥ 15 ETDRS letters

                    2. Percentage of subjects gaining ≥ 0 ETDRS letters

                    3. Mean change in ETDRS visual acuity

                    4. Change in total lesion size by fluorescein angiography

                    5. Change in total CNV size by fluorescein angiography

                    6. Number of rescue injections of Lucentis

Randomization:  Subjects will be randomly assigned in a 2:1 ratio to receive one of two treatment arms:

Arm A: A single surgical procedure with the Epi-Rad90TM Ophthalmic System and two injections of Lucentis (0.5 mg).  The first injection will be administered immediately following surgery and the second will be administered at the Month 1 visit; or

Arm B: Lucentis (0.5 mg) administered monthly for the first three injections followed by quarterly injections for two years.

Subject Participation:  This is a 3 year study.  All participants will return to the study clinic every month for the first 2 years then every 6 months for the final third year. 

Inclusion/Exclusion Criteria:

Please see enclosed sheet for the criteria

For more information contact Kris Dietzman at 263-9035 or Guy Somers at

262-9424

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Allergan

A 6 Month, Single Masked, Multicenter, Randomized, Controlled Study to Assess the Safety and Efficacy of 700 µg Dexamethasone Posterior Segment Drug Delivery System Applicator System as Adjunctive Therapy to Lucentis Compared with Lucentis Alone in the Treatment of Patients with Choroidal Neovascularization Secondary to Age-Related Macular Degeneration ~ POSURDEX

Principal Investigator:  Michael Altaweel, MD

Study Coordinator: Angie Wealti

Study Treatment:  700 µg Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS Applicator System ~ referred to as “DEX”)

Phase: 2

Study Objective:  To evaluate the safety and efficacy of DEX as adjunctive therapy to Lucentis compared with sham DEX plus Lucentis in patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration.

Overall Study Design:  This study will be conducted in 2 cohorts of patients with CNV secondary to AMD.  Cohort 1 will consist of patients who have never received treatment for AMD in the study eye.  Cohort 2 will consist of patients who have previously received treatment for AMD in the study eye.  The enrollment for both cohorts will start simultaneously, and each cohort will enroll approximately 100 patients.

Patients, in the opinion of the investigator, who require Lucentis therapy to treat AMD may be screened for study participation.  At the completion of the screening visit, eligible patients, in the opinion of the investigator, will receive a Lucentis treatment in the eye selected as the study eye (first Lucentis injection).  At baseline (Day 1), patients who meet Lucentis retreatment criteria will be reevaluated for study eligibility and, if eligible, in the opinion of the investigator, will be randomly assigned to Lucentis Alone or Adjunctive Therapy.  Randomized patients will receive up to 1 DEX or 1 sham DEX and up to 6 additional Lucentis injections in the study eye.  To mask the study, sham DEX will be given to patients in the Lucentis Alone group.

Inclusion/Exclusion Criteria:  Please see enclosed sheet for the criteria.

For more information contact Angie Wealti at 265-7557

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Regeneron:  A Randomized, Double Masked, Active Controlled Phase III Study of the Efficacy, Safety, and Tolerability of Repeated Doses of Intravitreal VEGF Trap in Subjects with Neovascular Age-Related Macular Degeneration (VGFT-OD-0605)

Principal Investigator:  Michael Altaweel, MD

Study Coordinators:  Angie Wealti, Kris Dietzman, Jennie Perry-Raymond

Primary Objective:  To assess the efficacy of intravitreal (ITV) administered VEGF Trap compared to ranibizumab in a non-inferiority paradigm in preventing moderate vision loss in subjects with all subtypes of neovascular AMD. 

Secondary Objectives: 

• To assess the safety and tolerability of repeated ITV administration of VEGF Trap in subjects with all sub-types of neovascular AMD for periods up to 2 years

• To assess the effect of repeated ITV administration of VEGF Trap on Vision-Related Quality of Life (QLF) in subjects with all sub-types of neovascular AMD, as assessed using the NEI VFQ-25 questionnaire. 

Study Design:  VGFT-OD-0605 is a double-masked, randomized, Phase III study.  Subjects will be randomly assigned in a 1:1:1:1 ratio to 1 of 4 dosing regimens:  1) 2 mg VEGF Trap administered every 4 weeks (2Q4), 2) 0.5 mg VEGF Trap administered every 4 weeks (0.5Q4), 3) 2 mg VEGF Trap administered every 8 weeks (2Q8), and 4) 0.5 mg ranibizumab administered every 4 weeks (RQ4); subjects assigned to (2Q8) will receive the 2 mg injection every 4 weeks to week 8 and then a sham injection at interim 4-week visits (when study drug is not to be administered) during the first 52 weeks of the study.  (No sham injection will be given at Week 52). 

Each subject is scheduled to be on study for 96 weeks.  Thus, the study duration will be 96 weeks plus the recruitment period.  For the first 52 weeks (Year 1), subjects will receive an ITV or sham injection in the study eye every 4 weeks.  During the second year of study, subjects will be evaluated every 4 weeks and will receive an ITV injection at least every 12 weeks.  During this period, injections may be given as frequently as every 4 weeks, but no less frequently than every 12 weeks.  During the second year of the study, sham injections will not be given. 

If a subject’s fellow eye requires treatment for AMD at study entry, or during the subject’s participation in the study, the fellow eye can receive any FDA approved treatment for wet AMD.  Subjects who receive treatment for the fellow eye should remain in the study.  Safety for the fellow eye will be monitored, and systemic adverse events will be collected. 

Sample Size:  Approximately 1200 subjects will be enrolled with a target enrollment of 300 subjects per treatment arm. 

Inclusion/Exclusion Criteria:  Please see the enclosed sheet for the criteria. 

For more information contact Angie Wealti at 265-7557, Kris Dietzman at

263-9035, or Jennie Perry-Raymond at 265-4659

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Topcon:  Reproducibility of Topcon SC-OCT and Comparison to Stratus TD-OCT

Principal Investigator:  Ronald Danis, MD

Study Coordinator:  Jennie Perry-Raymond

Rationale:  The development and commercialization of the Time Domain OCT (TD-OCT) over the past 17 years has lead to widespread use of these machines for clinical and research application.  Given the lack of competition, the single-source TD-OCT has become commonplace to the extent that the outputs of this instrument and the standardized reports that are generated have extensively guided clinical care and research.  The challenge for new OCT technology, Spectral Domain OCT (SD-OCT) now entering the marketplace, Is to assure physicians that the new instrument has similar reports and measurements with which they are familiar and that the measurements are comparable to the TD-OCT.  The SD-OCT is expected to demonstrate less variability of measurements and greater resolution of morphology.  A comparison of SD-OCT with TD-OCT is indicated to determine how the measurements and resolution of morphology compare between them. 

Recruitment:  Patients from the Retina Clinic at University Station in Madison, Wisconsin who are receiving an OCT scan for usual care of their retina disease will be recruited.  The patients will not be charged for the SD-OCT scans.  Patients will be paid $10 for their time.  140 eyes of at least 70 subjects will be enrolled in this study. 

Eligibility:  Eligible subjects will be having TD-OCT scanning for known retinal disease as part of their standard care.  The subject population will be stratified by disease type: no more than 70 eyes of the sample may be neovascular AMD.  The remaining enrollees will have known or suspected macular edema or vitreoretinal interface problems.  Because fellow eyes will also be scanned, the sample will include some eyes without retinal disease. 

Procedures:  Subjects will be asked to have a total of 4 OCT scans performed on each eye: replicate measurements with the TD-OCT and then replicate measurements with the SD-OCT. 

For more information contact Jennie Perry-Raymond at 265-4659 or any of the other Study Coordinators

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Comparison of AMD Treatment Trials (CATT)  Lucentis – Avastin Trial

Principal Investigator(s):  Suresh Chandra, MD and Michael Altaweel, MD

Study Coordinator(s):  Kris Dietzman, Angie Wealti, Jennie Perry-Raymond

Objective:  Evaluate the relative efficacy and safety of treatment of subfoveal neovascular AMD with Lucentis on a fixed schedule, Avastin on a fixed schedule, Lucentis on a variable schedule, and Avastin on a variable schedule. 

Major Eligibility Criteria: 

Active subfoveal choroidal neovascularization (CNV)

Subretinal hemorrhage and fibrosis <50% of total lesion area

Visual acuity (VA) 20/25-20/320

Age ≥50 yrs

≥1 drusen (>63µ) in either eye or late AMD in fellow eye

No previous treatment for CNV in study eye

No other progressive retinal disease likely to compromise VA

No contraindications to injections with Lucentis or Avastin

Masking: VA examiner; image graders masked to drug and schedule; Ophthalmologist masked to drug

Treatments: 

• Lucentis on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis every 4 weeks or to variable dosing.
• Avastin on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin every 4 weeks or to variable dosing.
• Lucentis on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
• Avastin on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.

Sample Size:  300 per group, or 1200 total

Follow-up:  Every 4 weeks through 2 years

Inclusion/Exclusion Criteria:  Please see enclosed sheet for the criteria.

For more information contact Kris Dietzman at 263-9035, Angie Wealti at 265-7557, or Jennie Perry-Raymond at 265-4659

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A NATURAL HISTORY STUDY OF MACULAR TELANGIECTASIA THE MACTEL STUDY – MACTEL

Principal Investigator: Barbara Blodi, MD

Study Coordinator:  Shelly Olson

Synopsis:

This study is a prospective, cross-sectional study of participants with diagnosis of macular telangiectasia.  At least 200 participants will be enrolled and all affected subjects will undergo examinations.  A complete family history will be solicited.  First degree relatives (primary siblings; secondary parents) of the proband will be actively recruited and asked to contribute a blood sample for genotyping and analysis of markers of systemic disease as well as undergoing a complete ophthalmologic examination. 

Participants genetic information will not be revealed to other family members or other people, including issues of adoption and paternity, which may be discovered from this study.  Only in the unlikely situation where such information has direct medical implications for the participant or his/her family will these issues be discussed with the participant.  Published information regarding the participant’s family tree will keep the identity of the participant and family members coded so as to maintain confidentiality. 

Inclusion Criteria:

All subjects of at least eighteen years of age with a diagnosis of macular telangiectasia are eligible.  The subjects should not have diabetic retinopathy with 10 or more microaneurysms  and/or small retinal hemorrhages and should not have other confounding ocular conditions that may now or in the future complicate the evaluation of macular telangiectasia.  Subjects with known allergies to fluorescein or indocyanine dye, iodine or iodine-containing dyes will also by excluded. 

For more information contact Shelly Olson at 263-7169

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AGE-RELATED EYE DISEASE STUDY 2 - AREDS 2

Principal Investigator: Suresh Chandra, MD and Barbara Blodi, MD

Study Coordinator:  Shelly Olson

Synopsis: 

A Multi-center, Randomized Trial of Lutein, Zeaxanthin, and Omega-3 Long-Chain Polyunsaturated Fatty Acids (Docosahexaenoic acid [DHA] and Eicosapentaenoic acid [EPA] in Age-Related Macular Degeneration. 

The primary objective is to see if nutritional pills with lutein and zeaxanthin and/or omega-3 long-chain polyunsaturated fatty acids, specifically docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) have a beneficial effect on AMD when compared to placebo. 

We will be recruiting approximately 150 patients here at the U.W.  Approximately 4000 people will participate in this study at various medical centers in the United States.  Patient participation will last until 2012 and will require 2 visits in the first 3 months of the study and then one visit each year for the remainder of the study.  At 3 months and 6 months after your second visit during the first year and then every 6 months in between study visits the patients will also receive a phone call. 

There will be 1 of 4 study treatment groups:

• Lutein/zeaxanthin and a placebo that resembles the DHA/EPA pill;
• DHA/EPA and a placebo that resembles the lutien/zeaxanthin pill;
• Lutein/zeaxanthin and DHA/EPA,
• Placebos resembling the lutein/zeaxanthin pills and the DHA/EPA pills.

For more information contact Shelly Olson at 263-7169

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BRAINPORT

Principal Investigator:  Michael Ip, MD

Study Coordinator:  Barbara Soderling

Objective:

The primary outcome of this study will be to test the ability of the HMI prototype device, following the proper training, to improve visual function in these patients.  A variety of function tests will be performed.  Additional outcomes of this proposal include the ease of use of the prototype device and acceptability of the device from the patient’s perspective (cosmesis). 

Inclusion Criteria: 

• Age 55 years or older
• Diagnosis of end-stage Age-Related Macular Degeneration in both eyes.
• Disciform scar formation present or geographic atrophy.  A disciform scar is defined as “sheets or mounds of yellow-white subretinal tissue”. 
• The disciform scar must be between 2 DA and 16 DA is size
• ETDRS Visual Acuity of 24 letters or less (20/320) in each eye

Exclusion Criteria:

• Inability to provide informed consent
• Significant lens or media opacity
• Treatment for exudative AMD performed within the last 6 months.  Prior treatment includes Photodynamic Therapy (PDT), any pharmacologic therapy (e.g. Macugen), or any surgical or laser treatment. 
• Any intraocular surgery performed within the last 2 months (e.g. YAG capsulotomy, cataract surgery, retinal detachment surgery). 

For more information contact Barbara Soderling at 263-7168

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Diabetic Retinopathy Clinical Research Network (DRCR)

A Randomized Trial Comparing Intravitreal Triamcinolone Acetonide and Laser Photocoagulation for Diabetic Macular Edema.

Principal Investigator: Justin Gottlieb
Study Coordinator: Kathryn Burke

Synopsis:
To determine whether intravitreal triamcinolone acetonide injections at doses of 1 mg or 4 mg produce greater benefit, with an acceptable safety profile, than macular laser photocoagulation in the treatment of diabetic macular edema.
To compare the efficacy and safety of the 1 mg and 4 mg triamcinolone acetonide doses.
This is a 36 month study with 4 month interval follow-up visits with safety visits at day 4 and week 4 after injections.

Recruitment/Eligibility:
- Greater than 18 years old
- Diagnosis of diabetes Mellitus type 1 or type 2
- Best corrected visual acuity of >=24 letters (20/320) and <=68 letters (20/40)
- Mean retinal thickness on 2 OCT measurements >=250 microns in the central subfield.

For more information contact Kathryn Burke at (608) 263-7172.

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Diabetic Retinopathy Clinical Research Network (Study#1A)

Principal Investigator: Justin Gottlieb, MD
Study Coordinator: Kathryn Burke

Synopsis:
The study compares two types of laser treatments in the treatment of diabetic macular edema. One treatment now used is called the “standard laser method.” The alternative laser treatment, “mild macular grid method” is milder in intensity, but more extensive in number.

Recruitment/Eligibility: Enrollment is currently closed and enrolled patients are still being followed.

For more information contact Kathryn Burke at (608) 263-7172.

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SCORE Trial

The Standard Care vs. COrticosteroid for Retinal Vein Occlusion (SCORE) study.

Primary Investigator: Michael Altaweel, MD
Study Coordinator: Jennie Perry-Raymond

Synopsis:
Two Randomized Trials to Compare the Efficacy and Safety of Intravitreal Injection(s) of Triamcinolone Acetonide with Standard Care to Treat Macular Edema: One for Central Retinal Vein Occlusion and One for Branch retinal Vein Occlusion.
The primary efficacy outcome of this study is improvement by 15 or more letters from baseline in best-corrected ETDRS visual acuity score at the 12-month visit as determined by the ETDRS visual acuity protocol.  The primary outcome analysis will include the following three comparisons of the proportion of participants having a 15 ETDRS letter improvement from baseline to 1 year:

• 4 mg triamcinolone acetonide intravitreal injections with standard of care
• 1 mg triamcinolone acetonide intravitreal injections with standard of care
• 4 mg traiamcinolone acetonide intravitreal injections with 1 mg triamcinolone acetonide intravitreal injections

This is a 3 year trial with 4-month interval follow-up visits, safety visits are performed at Day 4 and month 1 after each injection.

Recruitment/Eligibility:
- Center-involved macular edema secondary to either CRVO or BRVO
- Documented edema for at least 3 months.
- ETDRS visual acuity 34-73 letters or 20/40 to 20/200.
- Mean retinal thickness on two OCT measurements of 250 microns or more

For more information contact Jennie Perry-Raymond at (608) 265-4659.

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