Closed Retina Trials

Home Vision Monitoring in AREDS2 for Progression to Neovascular AMD Using the ForeseeHome Device
PI: G. Baker Hubbard, III, MD
Coordinator: Linda Curtis
Status: Closed.

General Summary: This study is to determine whether the use of this device which monitors vision helps to detect progression to wet AMD earlier than standard of care (Amsler grid). Half of the participants will receive the ForeseeHome Device, the other half will continue monitoring with Amsler grid. If an eye develops wet AMD during the study, we would also like to determine whether there is a difference in visual acuity between the 2 groups after 3 monthly injections of Lucentis or Avastin at month 3 and at 1 year.

Inclusion Criteria:
- Large drusen in both eyes or large drusen in one eye and advanced AMD in the other eye
- English speaking
- Demonstrate ability to understand use of the device after a tutorial
- Willing to return for eye exam if device detects changes

Exclusion Criteria:
- Retina disease other than AMD in the study eye
- Known reaction to fluorescein
- Eye exam by eye care professional more often than every 4 months

Contact: Linda Curtis, 404-778-4261
Last Updated: 07-31-2012; 05-20-2016

The AREDS2 Ancillary Spectral Domain Optical Coherence Tomography Study (A2ASDOCT)

PI: G. Baker Hubbard, MD
Coordinator: Linda Curtis
Status: Closed.

General Summary: The A2A SDOCT is a new method of gathering images of the eye to detect and measure changes in very small eye structures. In this study, the SDOCT imaging system is used to gather information from the reflection of light off the many structures in and beneath the retina. The images are stacked up to create a 3-dimensional picture of the back of the eye.

Inclusion Criteria:
- AREDS2 participants
- Normal control subject without AMD

Contact: Linda Curtis 404-778-4261
Updated:  05-20-2016

 

Longitudinal Study of Ocular Complications of AIDS

PI: Steven Yeh, MD
Coordinator: Deborah Gibbs, COMT, CCRC
Status: Closed enrollment

Summary: The Longitudinal Study of Ocular Complications of AIDS (LSOCA) is a multicenter, prospective, observational study of patients with AIDS. Patients with a diagnosis of AIDS according to the 1993 CDC criteria, with or without ocular opportunistic infections, will be enrolled. The objectives of the study are:

- To monitor secular trends in the incidence of CMV retinitis and other ocular complications of AIDS.
- To determine the effect of HAART-induced changes in immune status on the risk of CMV retinitis and other ocular complications of AIDS.
- To determine the characteristics (clinical, virologic, hematologic, and biochemical) of populations at high risk for CMV retinitis and other ocular complications of AIDS.

Approximately 2,800 patients will be enrolled in the study. Enrollment of patients with CMV retinitis at baseline will be between 300 and 600 patients. All patients will be on a 6-month followup schedule; and have telephone contacts at the 3-month time point between visits. Data will be collected from eye examinations, fundus photographs, visual function testing, medical history, quality of life assessment, laboratory studies, and collection of plasma and blood cells for banking. Banked specimens will be analyzed for HIV RNA levels and CMV DNA levels. Outcomes of primary interest are incidence of CMV retinitis, incidence of other ocular complications, and mortality. Other outcomes of interest include incidence of extra-ocular CMV disease, sequelae of AIDS-related eye disease (e.g., retinal detachment), visual function, quality of life, and incidence of complications of therapies for ocular complications.

Inclusion Criteria:
- CD4 less than 200 at any time on or after January 1, 2001. CD4 can be much higher now with or without eye problems.

And/or

- Within 45 days of being diagnosised with one of the following:
- - CMV
- - Herpetic retinitis
- - Toxoplasmic retinitis
- - Cryptococcal Choroidopathy
- - Pneumocystic Choroidopathy

Exclusion Criteria: None

Contact: Deborah Gibbs, COMT, CCRC, 404-778-5815 or pager 404-896-2711
Sponsor:
National Institutes of Health Johns Hopkins University

 

An Evaluation of Intravitreal Ranibizumab for Vitreous Hemorrhage Due to Proliferative Diabetic Retinopathy

PI: Blain Cribbs, MD
Coordinator: Judy Brower
Status: Closed.

General Summary: The purpose of this study is to determine whether Intravitreal injections of Ranibizumab decrease the proportion of eyes in which vitrectomy is performed by comparing with Intravitreal saline injections in eyes with vitreaous hemorrhage from proliferative diabetic retinopathy.

Clinical Summary: This study consists of 5 visits and 1 telephone call during 1 year. An Intravitreal injection (Ranibizumab or saline) will be given at baseline and possibly the next 2 study visits, which are 4 weeks and 8 weeks. A follow up visit is conducted at 12 and 52 weeks. ETDRS visual acuity, OCT, and eye exams are performed at each visit. Ultrasound may be needed. Blood is drawn for HbA1c unless results are available from previous 3 months.

Inclusion Criteria:
-
At least 18 years of age
- Type 1 or 2 Diabetes Mellitus
- Study eye must have vitreous hemorrhage from proliferative diabetic retinopathy causing vision impairment (precluding completion of PRP or precluding assessment of completeness of prior PRP)
- Willingness to wait at least 8 weeks to see if hemorrhage clears without having vitrectomy
- Visual aucity light perception or better

Exclusion Criteria:
- Prompt vitrectomy needed
- History of Intravitreal anti-VEGF for vitreous hemorrhage any time in the past or for any reason in the past 2 months
- History of vitrectomy
- History of major ocular surgery in prior 4 months
- Aphakia
- Uncontrolled glaucoma
- Yag capsulotomy in past 2 months
- Cardiac event requiring hospitalization, stroke, treatment for congestive heart failure in past 4 months

Contact: Judy Brower, MMSc, COMT 404-778-4725
Last Updated: 02-29-2012; 07-08-2013

 

An Observational Study in Individuals with Diabetic Retinopathy without Center-Involved SME Undergoing Cataract Surgery (Protocol Q)

PI: Jiong Yan, MD
Coordinator: Judy Brower, COMT
Status: Closed.

General Summary: Observational study only. The purpose is to determine how often center involved macular edema occurs 16 weeks after cataract surgery in eyes with diabetic retinopathy without center involved DME. This study is for diabetic patients about to have cataract surgery and consists of 3 study visits; one within 28 days before the surgery; one about 4 weeks after surgery; and one about 16 weeks after surgery.

Clinical Summary: Each study visit will consist of ETDRS refraction and visual acuity, OCT, and fundus exam.

Inclusion Criteria:
- At least 18 years of age.
- Presence of cataract.
- Diagnosis of Deabetes Mellitus.
- Presence of microaneurysms or at least mild NPDR on clinical exam
- Visual Acuity Light Perception or better.
- OCT central subfield thickness </= 250 microns.

Exclusion Criteria:
Any ocular condition other than cataract that might affect visual acuity.

Contact: Judy Brower, COMT, 404-778-4725
Last Updated: 02-29-2012; 07-08-2013

 

Comparison of AMD Treatments Trials (CATT)

PI: G. Baker Hubbard, MD
Coordinator: Lindy DuBois, MEd, MMSc, CO, COMT
Status: Completed.
Summary: Comparison of Lucentis vs Avastin and fixed vs variable dosing in the treatment of a new onset of wet AMD.

Inclusion Criteria:
- Age 50 and older.
- New untreated active wet AMD
- Vision worse than 20/25 and better than 20/300

Exclusion Criteria:
- Previous treatment or surgery for AMD in the study eye
- Other ocular disorders in the study eye
- Myopia greater than -8D
- Intraocular surgery within the last 2 months
- Pregnancy or lactation
- Significant uncontrolled systemic disease, infection, or inflammation

Contact: Lindy DuBois, 404-778-4443,
Sponsor: NIH/NEI
Last Updated:
07-31-2012

 

Implantable Miniature Telescope - Long Term Monitoring Extension (IMT002-LTME)
P I: Chris Bergstrom, MD
Coordinator: Jayne Brown
Status: Closed

General Summary: Participants will receive thorough ophthalmic examinations and specular microscopy in long term follow up.

Clinical Summary : Retina and cornea evaluations will be obtained for patients who have had surgery for the Implanable Miniature Telescope.

Inclusion Criteria: Patients who participated in the original miniature telescope implantation trial will return for long term follow up.

Exclusion Criteria:

Contact: Jayne Brown 404-778-4430 or Chris Bergstrom, MD, 404-778-4745
Date Posted: 05-06-2011; date posted as closed: 01-30-2012.

 

A Prospective, Multi-Center, Randomized, Double-Masked, Safety, Tolerability and Efficacy Study of Four Iontophoretic Doses of Dexamethasone Phosphate Ophthalmic Solution in Patients with non-Infectious Anterior Segment Uveitis
PI: Sunil Srivastava, MD
Coordinator: Jayne M. Brown
Status: enrollment closed

Summary:  This randomized trial will evaluate the efficacy of four doses of Dexamethasone using a novel delivery system for Anterior Uveitis.

Inclusion Criteria:
1. Non-infectious anterior uveitis defined as anterior chamber cell less than 1.5 (11 cells or less).
2. No elective ocular surgery during the study.

Exclusion Criteria:
1. Previous anterior uveitis episode less than 4 weeks prior to baseline.
2. Treatment for any type of uveitis in either eye within 2 weeks of presentation for enrollment.

Contact: Jayne M. Brown, 404-778-4430
Sponsor: EyeGate Pharmaceuticals, Inc.

 

Posurdex for Retinal Vein Occlusions
PI: Jiong Yan, MD
Coordinator: Jayne M. Brown
Status: No longer enrolling

Summary: The study purpose is to determine the efficacy and safety of Posurdex in the treatment of Branch Retinal and Central Vein Occlusion

Inclusion Criteria:
• Retinal thickness of greater than 300 um by OCT
• Visual decrease from macular edema to 20/50 to 20/200, ETDRS protocol
• 6 wk to 9 mo onset of CRVO
• 6 wk to 12 mo onset of BRVO

Exclusion Criteria:
• Glaucomatous damage or field loss
• Presence of an ocular condition preventing a 15 letter improvement in VA
• Uncontrolled systemic disease
• Diabetic retinopathy

Contact: Jayne M. Brown, 404-778-4430
Sponsor: Allergan

 

AEG211745 for subfoveal CNV
PI: Sunil Srivastava, MD
Coordinator: Jayne Brown
Status: Closed

Summary: A 2 year, phase 2, multicenter, randomized, controlled, masked dose finding trial to assess the efficacy of multiple intravitreal injections of AEG211745 in patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration. Primary response measurement is best corrected visual acuity after 2 years. Randomization is between variable does of AEG211745 and Lucentis.

Inclusion Criteria:
• CNV lesion size ≤ 12 MPS disc areas with 50% active CNV
• BCVA 20/400 to 20/40

Exclusion Criteria:
• Media opacities
• Significant ocular disease in addition to CNV

Contact: Jayne M. Brown, 404-778-4430,
Sponsor: Allergan

 

Thymosin Beta 4 for Diabetic Corneal Debridement
PI: Sunil Srivastava, MD
Coordinator: Jayne Brown
Status: Closed

Summary: A randomized, double mask placebo controlled, dose response, phase 2 study of the safety & efficacy of Thymosin Beta 4 in the treatment of diabetic patients’ corneal wounds resulting from epithelial debridement during vitrectomy. TB 4 may enhance healing by helping cells grow back and therefore be a significant treatment advance. 3 dosing groups will be administered post op for 14 days.

Inclusion Criteria:
• Diabetes with Glycosylated hemoglobin 7% - < 12%
• Scheduled vitrectomy

Exclusion Criteria:
• Keratitis
• Intra ocular or anterior segment surgery within 3 months of baseline

Contact: Jayne M. Brown, 404-778-4430
Sponsor: Regene Rx

 

Oral AEB071 for Uveitis
PI: Sunil Srivastava, MD
Coordinator: Jayne Brown
Status: Enrollment closed

Summary: This study will evaluate an oral immunosuppressant for non-infectious uveitis which may be taken alone or with other uveitis medications. A multicenter, single sequence, open label study to access the tolerability, safety, and efficacy of 2 weeks of oral AEBO71 300 mg twice daily followed by 6 weeks of AEB071 twice daily in treatment of macular edema in patients with non-infectious intermediate uveitis, posterior uveitis or panuveitis.

Inclusion Criteria:
• Macular edema greater than 250 um by Oct.
• Vitreous haze score greater than 1.0 but ≤ 3

Exclusion Criteria:
• Active chorodial neovascularization
• Macular edema associated with other ocular disease

Contact: Jayne M. Brown, 404-778-4430
Sponsor: Novartis

 

A Phase III, Multicenter, Randomized, Sham Injection-Controlled Study of the Efficacy and Safety of Ranibizumab Injection Compared with Sham in Subjects with Macular Edema Secondary to Central Retinal Vein Occlusion (CRUISE)
PI: G. Baker Hubbard, III, MD
Status: Closed.

Summary: To determine safety and efficacy of Ranibizumab (Lucentis) in the treatment of macular edema secondary to Central Retinal Vein Occlusions. This is a 12 month study consisting of 6 months of a “Treatment Period” and the final 6 months being the “Observation Period.” In the Treatment Period, one will receive .3 mg or .5 mg of Ranibizumab, or a sham treatment each month. Treatment is an intravitreal injection for those receiving medication. The sham group gets no medication during this time. In the Observation Period, there is not a sham group. Those on .3 mg continue to receive that dosage and those on .5 mg continue to receive that dosage. The sham group is switched to receive .5 mg during this period. Treatments are given during this period if VA and/or OCT qualifies.

Inclusion Criteria:
• Qualifying visual acuity on two visits within 28 days
• Diagnosis of Central Retinal Vein Occlusion within 12 months

Exclusion Criteria:
• History of laser for macular edema within 4 months prior to first study treatment
• History of intraocular corticosteroid use within 3 months prior to first study treatment
• History of any systemic anti- VEGF or pro-VEGF treatment within 6 months
• Use of oral corticosteroids to treat a chronic condition
• Stroke or heart attack within 3 months

Contact Information: Judy Brower, 404-778-4725
Sponsor: Genentech, Inc.

 

A Phase III, Multicenter, Randomized, Sham Injection-Controlled Study of the Efficacy and Safety of Ranibizumab Injection Compared with Sham in Subjects with Macular Edema Secondary to Branch Retinal Vein Occlusion (BRAVO)
PI: G. Baker Hubbard, III, MD
Coordinator: Judy Brower
Study Status: Closed


Summary: To determine safety and efficacy of Ranibizumab (Lucentis) in the treatment of macular edema secondary to Branch Retinal Vein Occlusions. This is a 12 month study consisting of 6 months of a “Treatment Period” and the final 6 months being the “Observation Period”. In the Treatment Period, one will receive .3 mg or .5 mg of Ranibizumab, or a sham treatment each month. Treatment is an intravitreal injection for those receiving medication.The sham group gets no medication during this time. There is the possibility of a rescue laser treatment at Month 3, 4, or 5 if certain criteria are met. In the Observation Period, there is not a sham group. Those on .3 mg continue to receive that dosage and those on .5 mg continue to receive that dosage. The sham group is switched to receive .5 mg during this period. Treatments are given during this period if VA and/or OCT qualifies. If rescue laser treatment is needed, it may be given at Month 9, 10, or 11. There can only be one laser treatment given during the Treatment Period and one during the Observation Period.

Inclusion Criteria:
• Qualifying visual acuity on two visits within 28 days
• Diagnosis of Branch Retinal Vein Occlusion within 12 months

Exclusion Criteria:
• History of laser for macular edema within 4 months prior to first study treatment
• History of intraocular corticosteroid use within 3 months prior to first study treatment
• History of any systemic anti VEGF or pro-VEGF treatment within 6 months
• Use of oral corticosteroids to treat a chronic condition
• Stroke or heart attack within 3 months

Contact: Judy Brower, 404-778-4725
Sponsor: Genentech, Inc.

 

Therasight® Pilot AMD Trial
PI: G. Baker Hubbard III, MD
Coordinator: Alcides Fernandes, MD
Status: This study is closed for enrollment.

Summary: The Emory Eye Center was the first in the United States to use a new system developed by the Theragenics Corporation. This clinical trial was designed to evaluate the safety and feasibility of the new TheraSight® Ocular Brachytherapy System for the treatment of sub-foveal choroidal neovascularization associated with exudative (wet) age-related macular degeneration (AMD). This is a study in which subjects are randomized to one time treatment of one of three doses of radiation applied directly to the sclera behind the macular area. Approximately 20 subjects will take part in this study at up to six clinical sites, Emory Eye Center among them. Favorable results of this study may be used to expand to a larger pivotal trial designed to further test the safety and effectiveness of the TheraSight® System.

Contact: Alcides Fernandes, MD, 404-778-2421
Sponsor: Theragenics Corporation

 

The Compassionate Use of CNTF Implant for Patients with Retinitis Pigmentosa
PI: Thomas M. Aaberg, MD
Coordinators: Alcides Fernandes, MD; Donna Leef, MMSc, COMT
Status: Enrollment is currently closed. Eleven patients were enrolled in this study.

Summary: This intraocular implant designed by Neurotech USA, of Lincoln, Rhode Island consists of an encapsulated cell technology product which contains the human ciliary neurotrophic factor (CNTF). Neurotrophic factors are agents with a promising ability to retard progression of neurodegenerative diseases and are effective in slowing photoreceptor degeneration in animal models of Retinitis Pigmentosa. In the Phase I safety trial, ten participants received CNTF implants in one eye. Human CNTF was delivered by cells transfected with the human CNTF gene and sequestered within capsules that were surgically implanted into the vitreous of the eye. The implant is designed to continuously release CNTF directly into the eye for sustained period of times. A Phase II study of this technology is currently being conducted in several national medical centers and enrollment is now completed. Emory University was approved to implant a few patients in a compassionate use basis.

Contact: Alcides Fernandes, MD, 404-778-2421, alcides@rmy.emory.edu
Sponsor: Neurotech USA

 

Age-Related Eye Disease Study 2 (AREDS 2)
PI: G. Baker Hubbard, III, MD
Coordinator: Linda Curtis
Status: Enrollment ended June 30, 2008

Summary: The National Eye Institute (NEI) is sponsoring the 5-year nationwide Age-Related Eye Disease Study2 (AREDS2) to learn what effect nutritional supplementation with Lutein and Zeaxanthin (carotenoids found in many fruits and vegetables) and/or the omega-3 fatty acids DHA and EPA (derived from fish oil)have on the progression to advanced age-related macular degeneration (AMD). AMD is the leading cause of vision loss in the United States for people over the age of 60.

Inclusion Criteria:
• Large drusen in both eyes or
• Large drusen in one eye and advanced AMD in the other eye.

Exclusion Criteria:
• Ocular disease in either eye, other than AMD (glaucoma, etc.)
• Previous retinal or other ocular surgical procedures (except for cataract surgery, YAG capsulotomy, laser or other treatments for advanced AMD).
• Any systemic disease with a limited 5-year survival.

Contact: Linda Curtis, 404-778-4261
Sponsor: NEI

 

Pilot Study in Individuals with Center-Involved Diabetic Macular Edema Undergoing Cataract Surgery (Protocol P)

PI: Jiong Yan, MD
Coordinator: Judy Brower, COMT
Status: Discontinued

General Summary: Observational study only. This study is for diabetic patients with macular edema about to have cataract surgery and consists of 2 study visits; one within 2 weeks before the surgery and the other about 16 weeks after the surgery.

Clinical Summary: Each study visit will consist of ETDRS refraction and visual acuity, OCT, and dilated eye exam. The doctor may decide photographs with fluorescein dye are needed.

The cataract surgery is not part of the study.

Inclusion Criteria:
- At least 18 years of age.
- Diagnosis of Diabetes Mellitus
- Visual Acuity Light Perception or better
- OCT central subfield thickness >/=250 microns

Exclusion Criteria: Any ocular condition other than cataract and DME that might affect visual acuity

Contact: Judy Brower, 404-778-4725 judy.brower@emoryhealthcare.org

Date Posted:  2/23/2010

Our Emory campus location:

Copyright © Emory Eye Center - All Rights Reserved | Emory Clinic Building B, 1365B Clifton Road, NE, Atlanta, Georgia 30322 USA