Article Date: 1/1/2007

05_05 ClinTrial p62-68

CLINICAL TRIAL UPDATE
 

DRY AMD

Study: Age-Related Eye Disease
Study II (AREDS II)

Sponsor: National Eye Institute

Status: Enrolling patients

Purpose: Investigate the effects of oral supplements of lutein/zeaxanthin and omega-3 fatty acids for the treatment of AMD. A secondary randomization will further refine the AREDS-type supplement by testing lower dose of zinc and eliminating beta-carotene

Design: Phase 3, randomized, prospective, multicenter trial

Number of Patients: 4000

Number of Clinical Centers: 80 plus

Inclusion Criteria: Age 55 years to
80 years; bilateral large drusen (>125 μm) or advanced AMD (neovascular AMD or geographic atrophy involving the center of fovea) in 1 eye only and presence of large drusen in the fellow eye

Exclusion Criteria: Choroidal neovascularization associated with other ocular diseases such as pathologic myopia, ocular histoplasmosis or posterior uveitis, other confounding ocular disease or surgical procedures (except for cataract surgery or YAG laser)

Information: http://www.nei.nih.gov/neitrials/viewStudyWeb.aspx?id=120
 


Study: OT-551

Sponsor: National Eye Institute

Status: Enrolling patients

Purpose: To investigate whether the topically applied antioxidant OT-551 can help slow progression of atrophic "dry" AMD

Inclusion Criteria: Age �50 years; geographic atrophy or the dry form of AMD in both eyes; no history of neovascular or "wet form" of AMD in either eye; have not participated in any other AMD clinical trial except using vitamins; no previous ocular surgery other than cataract surgery; not presently receiving chemotherapy; must be medically stable and able to complete the study; participation requires 7 visits over approximately 2 years, with vision testing and eye exams at each visit

Information: Ruby Lerner, RN
Phone: (301) 451-3437
Fax: (301) 480-2566
E-mail: lernerru@nei.nih.gov


Study: Measuring Reading Rehabilitation Outcomes

Sponsor: Department of Veteran Affairs

Status: Enrolling patients

Purpose: To measure the effectiveness of a newly-designed oculomotor training program for patients with AMD

Design: Educational, counseling, training, nonrandomized, double-blind, active control, crossover assignment, efficacy study

Number of Patients: 90

Inclusion Criteria: Established preferred retinal locus; fisual acuity of less than or equal to 20/70 and greater than or equal to 20/400 (in the better eye)

Exclusion Criteria: Major ophthalmologic and neurologic disease; choroidal neovascularization ("wet" AMD); moderate to severe media opacities; and cognitive impairment

Information: (312) 996-1466


Study: Safety Study in Retinal Transplantation for Dry AMD

Sponsors: Ocular Transplantation, National Neurovision Research Institute

Status: Enrolling patients

Purpose: To show that retinal transplantation can help to prevent blindness and to restore eyesight in patients with dry AMD.

Design: Treatment, nonrandomized, open label, active control, factorial assignment, safety/efficacy study

Number of patients: 10

Inclusion Criteria: Decreased entral visual acuity of 20/200 or worse in one eye by ETDRS vision testing for a duration of at least one year in the operated eye; vision in the nonoperated eye must be better than the operated eye; vision in the operated eye cannot be better than 20/200; >55 years of age; patient has undergone microperimetry and Goldmann visual field testing

Exclusion Criteria: Medical problems that are contraindicatory for short-term anesthesia; pregnancy; features of any condition other than AMD in the study eye (such as pathologic myopia or presumed ocular histoplasmosis) associated with choroidal neovascularization; history of choroidal neovascularization in the study eye; prior photodynamic therapy or Macugen therapy for choroidal neovascularization; history of uveitis, Coat's disease, diabetic retinopathy, glaucoma, or a cataract that prevents visualization of the posterior pole

Information: (502) 636-2823


WET AMD

Study: Clinical Trial to Explore the Safety and Efficacy of Injections of Macugen When Given Every 6 Weeks in Subjects With AMD

Sponsor: Eyetech/Pfizer

Status: Enrolling patients

Purpose: To explore the safety and efficacy of Macugen given as maintenance therapy in patients who have had initial success with another AMD treatment

Design: Treatment, non-randomized, open-label, uncontrolled, single group assignment

Number of Patients: 1000

Inclusion Criteria: Patients must have 1, but not more than 3, prior treatments for neovascular AMD

Information: (866) 622-8436


Study: Open-Label Posterior Juxtascleral Injections of Anecortave Acetate 15 mg Dose for Long-Term Use in Patients With AMD

Sponsor: Alcon

Status: Enrolling patients

Purpose: To study the efficacy of anecortave acetate 15 mg administered every 6 months over 24 month in treating wet AMD

Design: Treatment, non-randomized, open-label, uncontrolled, single group assignment, safety/efficacy study

Number of Patients: 150

Inclusion Criteria: Patients with subfoveal exudative age-related macular degeneration (AMD) who were enrolled in Alcon Study C-98-03

Information: (817) 568-6747, intldev@alconlabs.com


Study: Safety and Efficacy of Repeated Intravitreal Administration of VEGF Trap in Patients with Wet AMD

Sponsor: Regeneron Pharmaceuticals

Status: Enrolling patients

Purpose: To assess the ocular and systemic safety and tolerability of repeated intravitreal doses of VEGF Trap in patients with subfoveal CNV due to AMD

Design: Phase 2, randomized, double-blind, dose comparison, parallel assignment, safety/efficacy

Number of Patients: 150

Inclusion Criteria: Age >50 years; subfoveal CNV secondary to AMD; central retinal (including lesion) thickness �300 μm as measured by OCT; ETDRS BCVA of 73-34 letters

Exclusion Criteria: History of any vitreous hemorrhage within 4 weeks prior to day 1; aphakia; significant subfoveal atrophy or scarring; prior treatment with the following in the study eye: subfoveal thermal laser therapy, submacular surgery, or other surgical intervention for the treatment of AMD; extrafoveal laser coagulation treatment within 12 weeks prior to day 1; PDT within 12 weeks prior to visit 2 (day 1); pegaptanib sodium within
8 weeks of visit 2 (day 1); juxtascleral steroids or anecortave acetate within 24 weeks (6 months) prior to visit 2 (day 1); intravitreal administration of triamcinolone acetonide or other steroids within 24 weeks prior to visit 2 (day 1) unless no visible residue of drug substance can be seen in the vitreous cavity using indirect ophthalmoscopy; prior systemic or intravitreal treatment with VEGF Trap, ranibizumab, or bevacizumab

Information: Regeneron, VEGF.Trap@regeneron.com


Study: Infliximab, Sirolimus, and Declizumab to Treat AMD

Sponsor: National Eye Institute

Status: Enrolling patients

Purpose: To examine whether anti-inflammatory medicines infliximab, sirolimus, or declizumab, when given with a patient's current therapies, will prevent the growth of new blood vessels in the eye in patients with AMD

Design: Phase 2, open-label, randomized, single center

Number of Patients: 20

Inclusion Criteria: Age >55 years; AMD with drusen �63 μm; any antiangiogenic therapy in study eye within 7 days of beginning study treatment; vision 20/40-20/400 in study eye; CNV under fovea, as defined by FA features detailed in study criteria; occult CNV with no classic lesions to meet study criteria

Exclusion Criteria: CNV in the study eye associated with other ocular diseases such as pathologic myopia, ocular histoplasmosis, or posterior uveitis; presence of geographic atrophy under the fovea in the study eye; evidence of retinal angiomatous proliferation as suspected by the presence of intraretinal hemorrhage, intraretinal leakage, adjoining serous PED, or the presence of a connecting retinal vessel; presence of chorioretinal anastomosis; decrease in vision due to retinal disease not attributable to CNV or significant media opacity; presence of fibrosis, hemorrhage, pigment epithelial detachments, or other hypofluorescent lesions obscuring >50% of CNV lesion; history of other antiangiogenic treatment or treatment of CNV (not including PDT and pegaptanib sodium) in study eye with TTT or other local treatment; please see complete trial information for additional exclusion criteria

Information: National Eye Institute, prpl@mail.cc.nih.gov


Study: A Clinical Trial to Explore the Safety and Efficacy of 3 Different Doses of Pegaptanib Sodium in Patients With Wet AMD

Sponsor: (OSI) Eyetech/Pfizer

Status: Recruiting

Purpose: To compare the ability of
3 different doses of pegaptanib sodium to safely and effectively minimize fluid leakage within the eye, thereby stabilizing or improving vision in patients with wet AMD; the study will also examine the effects of pegaptanib sodium on the cornea and sensory retina of patients with wet AMD

Design: Phase 4, randomized, double-blind

Number of Patients: 262

Inclusion Criteria: Age >50 years; subfoveal CNV due to AMD; BCVA in the study eye between 20/40-20/320;
normal electroretinogram and
corneal endothelial cell density of 1500 cells/mm2 or more

Exclusion Criteria: Any prior PDT with Visudyne or thermal laser to the study eye

Information: (866) 622-8436


Study: Macugen Alone vs Macugen in Combination with PDT With Visudyne in Patients With AMD

Sponsor: (OSI) Eyetech/Pfizer

Status: Enrolling patients

Purpose: To compare whether Macugen in combination with PDT with Visudyne is safe and effective in slowing the leakage of fluid within the eye and thereby stabilizing or improving vision when compared to Macugen alone

Design: Phase 3b/4, randomized, double-blind

Number of Patients: 360

Inclusion Criteria: Age >50 years; subfoveal CNV due to AMD with predominantly classic lesion composition; BCVA in the study eye between 20/40-20/200

Exclusion Criteria: Any prior PDT with Visudyne or AMD thermal laser to the study eye

Information: (866) 622-8436


Study: MRVT-920101-OPH005

Sponsor: Miravant Pharmaceuticals, Inc.

Status: Enrolling patients

Purpose: Confirm the efficacy and safety of rostaporfin (PHOTREX) photodynamic therapy in the treatment
of classic and occult subfoveal choroidal neovascularization
associated with AMD

Design: Multicentered, multinational, randomized, double-masked, placebo-controlled, phase 3

Number of Patients: 660

Site(s): Multiple European Union and non-European locations

Inclusion Criteria: Age >50 years; at least 1 subfoveal CNV membrane secondary to AMD that can be demonstrated by fluorescein angiography; best corrected VA score of 20/40–20/200

Information: (800) 685-2959


Study: Visudyne with Intravitreal Triamcinolone Acetonide (VisTA) Trial

Sponsor: LuEsther T. Mertz Retinal Research Center

Status: Enrolling patients

Purpose: Evaluate the effect of PDT in conjunction with intravitreous triamcinolone acetonide in subjects with occult or minimally classic subfoveal CNV secondary to AMD

Design: Randomization 1:1:1, PDT and 0 mg of triamcinolone/PDT, 1 mg of triamcinolone/PDT, 4 mg of triamcinolone

Inclusion Criteria: Age >50 years; occult or minimally classic subfoveal CNV, presence of blood associated with the lesion, vision loss or growth of lesion objectively recorded within preceding 3 months; baseline VA score between 20/40–20/400, lesion �5400 μm

Exclusion Criteria: Predominantly classic CNV, additional eye disease, CNV not involving geometric center of FAZ; inability to be photographed; fluorescein allergy; photophobia; lens opacities expected to progress during study; previous treatment for CNV, other than confluent laser photocoagulation (eg, PDT, submacular surgery, radiotherapy, macular grid); participation in another clinical trial; IOP >21 mm Hg on or off meds; prior treatment with another antiangiogenic compound within
6 months of screening; inability to comply with all study-related procedures; concomitant therapy with systemic or topical corticosteroids or NSAIDs (chronic concomitant therapy is defined as multiple doses taken daily for 3 or more consecutive days at any time during the course of the 12-month study); a low dose of ASA (up to 100 mg PO qd) taken for prophylaxis of MI and/or stroke is permitted during the study; concomitant coumadin therapy

Number of Patients: 120

Information: Namrata Saroj, (202) 605-3777


Study: Preservative-free Triamcinolone Acetonide (PFTA)

Sponsor: QLT Inc., National Eye Institute

Status: Enrolling patients

Purpose: Investigate the long-term safety and potential efficacy of PFTA in patients with wet AMD (all types) undergoing Visudyne therapy

Design: Phase 3, randomized, prospective

Number of Patients: 300

Inclusion Criteria: Age �50 years; in the study eye, diagnosis of AMD defined by the presence of drusen larger than 63 μm; visual acuity of 20/40 to 20/200
(73-34 letter score) as measured on an ETDRS chart; in the study eye, the presence of choroidal neovascularization under the fovea

Exclusion Criteria: Choroidal neovascularization, in the study eye, associated with other ocular diseases such as pathologic myopia, ocular histoplasmosis, or posterior uveitis, etc.; presence of geographic atrophy under the fovea in the study eye; the presence of a chorioretinal anastomosis; presence of fibrosis, hemorrhage, pigment epithelial detachments, and other hypofluorescent lesions obscuring greater than 50% of the CNV lesion

Information: (301) 496-5248


Study: Squalamine

Sponsor: Genaera Corporation

Status: Enrolling patients

Purpose: Evaluate the safety and efficacy of intravenously administered squalamine as a first-line therapy for wet AMD

Design: Phase 2, randomized, double-masked, controlled study; 2 dose levels once weekly for 4 weeks, followed by maintenance doses once every 4 weeks through week 48; at the end of therapy, each patient will be followed for an additional year

Number of Patients: 100

Site(s): Multicenter

Information: (610) 941-4020


Study: Genetic Factors in AMD

Sponsor: National Eye Institute

Status: Enrolling patients

Purpose: To examine whether certain polymorphisms predispose people to develop AMD

Design: Screening

Number of Patients: 400

Inclusion Criteria: (AMD patients) Age �50 years; diagnosis of advanced AMD defined by geographic atrophy and/or CNV with drusen of any size in at least
1 eye; (Control patients) Age >70 years; absence of drusen or no more than
5 drusen <63 μm; absence of other diagnostic criteria for AMD

Exclusion Criteria: Presence of retinal disease involving the photoreceptors and/or outer retinal layers other than AMD loss such as high myopia, retinal dystrophies, central serous retinopathy, vein occlusion, diabetic retinopathy and uveitis or similar outer retinal diseases that have been present prior to the age of 50; opacities of the ocular media; limitations of papillary dilation or other problems sufficient to preclude adequate
stereo fundus photography (occluded pupils due to synechia, cataracts,
vitreous haze, and opacities due to ocular diseases)

Information: (800) 411-1222


Study: Triple Therapy - PDT Plus IVD and Intravitreal Ranibizumab vs Monotherapy - Intravitreal Ranibizumab Alone for the Treatment of AMD

Sponsor: Bay Area Retina Associates, QLT, Inc.

Status: Enrolling patients

Purpose: To compare triple therapy using Photodynamic therapy, intravitreal Dexamethasone and intravitreal Ranibizumab injections versus monotherapy with intravitreal Ranibizumab alone for the treatment of AMD.

Design: Treatment, randomized, singleblind, active control, crossover assignment, efficacy study

Inclusion Criteria: Minimally classic or occult lesions; Classic lesions greater than 50% of the total lesion area; lesion must be less than 12 disc areas; CNVM must be greater than or equal to 50% of the total lesion size; some evidence of recent disease progression; occult lesions must show recent activity progression with respect to vision, subretinal hemorrhage or subretinal fluid and be less than 12 disc areas in total size; age >= 50 years.

Exclusion Criteria: Pigment epithelial detachment greater than 50% of the total lesion size; previous treatment for AMD in the study eye; previous intravitreal drug delivery in the study eye; history of vitrectomy in the study eye; fibrosis or atrophy involving the center of the fovea in the study eye; neovascular membrane from any other concurrent retinal disease such as high myopia (SER > -8D), histoplasmosis or other ocular inflammatory disease; known history of glaucoma and on more than one topical medication; history of corneal transplant in the study eye; co-existing macular disease such as DME; active intraocular inflammation in the study eye; history of allergy to fluorescein

Contact: (925) 943-6800


Study: Imatinib Mesylate Combined With Intravitreal Ranibizumab in the Treatment of Choroidal Neovascularization Secondary to AMD

Sponsor: Vitreoretinal Macula Consultants of New York; Genentech

Status: Enrolling patients

Purpose: To determine if Lucentis combined with imatinib mesylate will help treatment in patients with newly diagnosed choroidal neovascularization

Design: Treatment, nonrandomized, open-label, active control, parallel assignment, safety/efficacy study

Number of Patients: 15

Inclusion Criteria: BCVA letter score in the study eye between 73-24 (approximately 20/40 to 20/320) using an ETDRS chart; CNV lesion of any type in the study eye; evidence that CNV extends under the geometric center of the foveal avascular zone area of the CNV must occupy at least 50% of the total lesion; lesion must be �4000 μm in greatest linear dimension (GLD)

Exclusion Criteria: History of prior PDT, external-beam radiation, subfoveal focal laser photocoagulation, submacular surgery, or transpupillary thermotherapy in the study eye; atrophy under the center of the fovea; angioid streaks, presumed ocular histoplasmosis syndrome, myopia (>6 diopters), or choroidal neovascularization secondary to other causes than AMD; receiving or require chronic concomitant therapy with systemic (>5 mg) or ocular corticosteroids.

Contact: (212) 452-6902


Study: Investigating Age-Related Macular Degeneration

Sponsor: National Eye Institute

Status: Enrolling patients

Purpose: To examine an Amish community to investigate genetic factors in the development of AMD

Design: Natural history

Number of patients: 1000

Inclusion Criteria: All Amish individuals, ages 50 and older

Information: (301) 496-6583


Study: Study To Determine Safety/Efficacy of Lucentis
For Treatment Of Retinal Angiomatous Proliferation Secondary To AMD

Sponsor: The National Retina Institute/ Genentech

Status: Enrolling patients

Purpose: To determine the safety & efficacy of ranibizumab for the treatment of retinal angiomatous proliferation secondary to AMD

Number of Patients: 20

Inclusion Criteria: Age > 50 years; definite characteristic signs of age related macular degeneration (AMD) including drusen; presence of retinal angiomatous proliferation as determined by clinical signs (intra retinal hemorrhage, retinal edema, cystic retinal edema) and angiography (occult leakage on fluorescein angiography, hot spot on static ICG, visible RAP lesion of high speed ICG)

Exclusion Criteria: Prior treatment with verteporfin, external-beam radiation therapy, or transpupillary thermotherapy in the study eye; treatment with verteporfin in the non-study eye less than 7 days preceding Day 0; previous participation in a clinical trial (for either eye) involving anti angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors, etc.); previous subfoveal focal laser photocoagulation involving the foveal center in the study eye; laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding Day 0; history of vitrectomy, submacular surgery, or other surgical intervention for AMD in the study eye; previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals)

Contact: (301) 986-8747


Study: Ultrasonic Evaluation of Ocular Tissues

Sponsor: Weill Medical College of Cornell University/Riverside Research Institute

Status: Enrolling patients

Purpose: To improve diagnosis and treatment monitoring of ophthalmic disease by improving diagnostic ultrasound techniques

Design: Screening, cross-sectional, defined population, retrospective/prospective study

Number of Patients: 150

Inclusion Criteria: Diagnosis of AMD

Contact: (212) 746-6106


Study: Ranibizumab in Hemorrhagic Choroidal Neovascularization Trial

Sponsor: Johns Hopkins University/ Genentech

Status: Enrolling patients

Purpose: To look at the effects of an experimental drug, ranibizumab, on a condition called "predominantly hemorrhagic subfoveal choroidal neovascularization (CNV)" due to wet AMD

Number of Patients: 10

Inclusion Criteria: Age >50 years old; must have media clear enough to permit fundus photography, fluorescein angiography, and optical coherence tomography

Exclusion Criteria: Known hypersensitivity to humanized monoclonal antibodies; history (within past 6 months) or evidence of severe cardiac disease (apparent in electrocardiogram abnormalities, clinical history of unstable angina, acute coronary syndrome, myocardial infarction, revascularization procedure within
6 months prior to baseline, atrial or ventricular tachyarrhythmias requiring ongoing treatment); history of stroke within
6 months of study entry; current acute ocular or periocular infection; any major surgical procedure within one month of study entry; known serious allergies to fluorescein dye

Contact: (443) 257-9692


Study: Metabolic Mapping to Measure Retinal Metabolism

Sponsor: National Eye Institute

Status: Enrolling patients

Purpose: To test whether a new non-invasive technique can quickly and precisely measure retinal metabolism (the amount of energy retinal cells use)

Design: Diagnostic, nonrandomized, open-label, uncontrolled, single-group assignment, efficacy study

Number of Patients: 30

Inclusion Criteria: Presence of a natural lens in the study eye; age 60 years or older

Exclusion Criteria: Ocular disease (other than AMD) that confounds assessment of the retina including diabetic retinopathy, central serous choroidopathy, optic atrophy, retinal vein occlusion, active uveitis, significant explained or unexplained visual field loss, or any other type of retinopathy or retinal degeneration

Information: (800) 411-1222


SCREENING

Study: Evaluation and Treatment of Patients with Retinal Disease

Sponsor: National Eye Institute

Status: Enrolling patients

Purpose: To allow National Eye Institute physicians to increase their knowledge of retinal eye diseases and identify possible new avenues of research in this area

Design: Natural history

Number of patients: 500

Inclusion Criteria: Diagnosis of AMD

Exclusion Criteria: Inability to be followed for 3 years

Contact: (800) 411-1222


Study: Screening for Studies on Retinovascular Diseases

Sponsor: National Eye Institute

Status: Enrolling patients

Purpose: To help recruit patients for National Eye Institute (NEI) studies of the retina

Design: Natural history

Number of patients: 1500

Inclusion and Exclusion Criteria: Inclusion and exclusion criteria vary with the particular protocol for which a patient is being screened. In addition to those diagnoses currently under study, subjects with unknown conditions that require the establishment of a diagnosis may be eligible for inclusion in this study. All studies of retinovascular diseases require the subject to have minimum age of 18 years in both men and women.

Contact: (800) 411-1222


Study: Screening for Studies on Inherited Eye Diseases

Sponsor: National Eye Institute

Status: Enrolling patients

Purpose: To help recruit patients for National Eye Institute (NEI) studies on inherited eye diseases.

Design: Natural history

Number of Patients: 500

Inclusion and Exclusion Criteria: Inclusion and exclusion criteria vary with the particular protocol for which a patient is being screened. In addition to those diagnoses currently under study, subjects with unknown conditions that require the establishment of a diagnosis may be eligible for inclusion in this study. All studies require the subject to have minimum age of 18 years in both men and women.

Contact: (800) 411-1222


RETINAL IMAGING STUDIES

Study: Retinal Imaging in Patients With Inherited Retinal Degenerations

Sponsor: University of California-San Francisco/University of California-Berkeley

Status: Enrolling patients

Purpose: To determine whether the structure and function of the human retina can be studied with high resolution in patients with inherited retinal degenerations using the Adaptive Optics Scanning Laser Ophthalmoscope

Design: Natural history, longitudinal, defined population, prospective study

Number of Patients: 130

Inclusion Criteria: Subjects must have pupils that dilate to at least 6 mm diameter and must be willing to travel to UC Berkeley

Exclusion Criteria: Cataract; irregular corneal astigmatism (keratoconus); prior refractive surgery

Information: Jacque L. Duncan, MD, (415) 514-4241, duncanj@vision.ucsf.edu


Study: Novel Diagnostics for Ocular Structure

Sponsor: University of Pittsburgh/National Institutes of Health

Status: Enrolling patients

Purpose: To evaluate novel technologies for the assessment of ocular structure and function, including the scanning device called Optical Coherence Tomography (OCT).

Design: Natural history, longitudinal, defined population, retrospective/prospective Study

Number of patients: 500

Inclusion Criteria: Diagnosis of macular degeneration, diabetic retinopathy, and/or glaucoma

Exclusion Criteria: Media opacity (lens, vitreous, cornea); diagnosis of strabismus, nystagmus, or a condition that would prevent fixation

Information: Tammy J Capozzoli,
(412) 647-2375, capozzolitj@upmc.edu


Study: Optical Coherence Tomography of Retinal Abnormalities Associated With Choroidal Nevus, Choroidal Melanoma and Choroidal Melanoma Treated With Iodine-125 Brachytherapy

Sponsor: University of California, Los Angeles

Status: Enrolling patients

Purpose: To investigate imaging of intraocular tumors that may lead to improved diagnosis and monitoring of tumors within the eye

Study Design: Longitudinal, defined population, prospective study

Inclusion Criteria: Adults (18 years or older) with choroidal nevus greater than or equal to 3.0 mm in longest basal diameter, or greater than or equal to
1.25 mm in apical height; or choroidal melanoma located in the posterior pole (4 mm or less from the center of fovea or the border of the optic nerve head)

Exclusion Criteria: Ocular media opacity in the tumor eye that prevents adequate functional testing or imaging and prior or concurrent retinal or choroidal disease in the tumor eye that prevents adequate functional testing or imaging

Contact: (310) 206-7484


DIABETIC MACULAR EDEMA

Study: Evaluation of Vitrectomy for DME

Sponsor: Diabetic Retinopathy Clinical Research Network

Number of sites: 29

Number of patients: approximately 400

Status: Enrolling patients

Purpose: To provide information on the following outcomes in eyes with DME that undergo vitrectomy: visual acuity, retinal thickening, resolution of traction
(if present), surgical complications; to identify subgroups in which there appears to be a benefit of vitrectomy and subgroups in which vitrectomy does not appear to be beneficial; to obtain data that can be used to plan a randomized trial

Design: The study is designed as a prospective cohort study. A cohort study provides the opportunity to collect data prospectively using a standardized protocol to assess the potential benefits and risks of vitrectomy. The results can be used to determine whether proceeding with a randomized trial has merit and what the design of the trial should be. If a randomized trial is to be conducted, the results plus the cohort study experience can be used to help design the RCT protocol.

Inclusion/Exclusion Criteria: Age �18 years old, study eye with vitrectomy being performed as treatment of DME, study eye with best corrected visual acuity 20/800 or better (E-ETDRS visual acuity score �3 letters)

Information: http://public.drcr.net/studies/ProtocolD_vitrectomy/ProtDInfo.html


Study: An Observational Study of the Development of DME Following Scatter Laser Photocoagulation

Sponsor: Diabetic Retinopathy Clinical Research Network

Number of sites: 18

Number of patients: approximately 150

Status: Enrolling patients

Purpose: To determine the incidence and extent of macular edema following scatter laser photocoagulation surgery using OCT in eyes without macular edema prior to scatter laser photocoagulation, and to explore whether the incidence and extent of macular edema varies according to the number of sittings included in the treatment regimen

Design: Prospective, multicenter, nonrandomized clinical trial

Inclusion/Exclusion Criteria: Age �18 years, study eye with (1) OCT center point thickness �200 μm and (2) early proliferative or severe nonproliferative diabetic retinopathy for which investigator intends to perform full scatter photocoagulation in either 1 sitting or 4 sittings

Information: http://public.drcr.net/studies/ProtocolF_prp/ProtFInfo.html


Study: Subclinical DME Study

Sponsor: Diabetic Retinopathy Clinical Research Network

Number of sites: 18

Number of patients: Approximately 1000 patients will be enrolled in order to follow 220 patients

Status: Recruiting

Purpose: To determine how often study participants' eyes with subclinical DME (defined as no edema involving the center of the fovea as determined by biomicroscopy but with center point thickness on OCT of at least 200 μm but less than or equal to 299 μm) progress over a 2-year period to edema on OCT of at least 300 μm (which is almost always clinically apparent) and increase at least 50 μm from baseline or are treated for DME among individuals with more than minimal retinopathy (greater than level 20), and to determine mean OCT retinal thickness measurements and confidence intervals in subjects with diabetes and no or minimal nonproliferative diabetic retinopathy (level 20 or less)

Design: Prospective, multicenter, observational study. The study consists of a baseline phase and follow-up phase

Inclusion/Exclusion Criteria: Age �18 years, study eye with best corrected E-ETDRS acuity �74 letters (20/32 or better)

Information: http://public.drcr.net/studies/ProtocolG_subclinical/ProtGInfo.html


Study: FAME (Fluocinolone Acetonide in Macular Edema)

Sponsor: Alimera Sciences & Controlled Delivery Systems

Number of Sites: Approximately 100

Number of Patients: More than 900

Status: Phase 3 initiated

Purpose: To evaluate the safety and efficacy of sustained-release fluocinolone acetonide, at 2 doses, delivered via the Medidur intraocular sustained delivery system

Design: Double-masked, randomized, multicenter, parallel group, controlled study

Inclusion/exclusion Criteria: Patients diagnosed with DME, who have previously had laser treatment

Information: www.alimerasciences.com


Study: Reduction in the Occurrence of Center-threatening DME

Sponsor: Eli Lilly and Company

Status: Enrolling patients

Purpose: Determine whether ruboxistaurin can slow the progression of DME

Design: Randomization 1:1, ruboxistaurin/placebo

Inclusion Criteria: Type 1 or type 2 diabetes; >18 years; nonclinically significant DME; mild to moderate diabetic retinopathy in the study eye or vitreous hemorrhage in the study eye; relatively good vision (20/30 or better)

Exclusion Criteria: Surgery or laser treatment in the study eye; glaucoma in the study eye; HbA1c >11%, or systolic blood pressure <170 mm Hg

Information: (877) 285-4559


Study: Macugen in Diabetic Macular Edema and Diabetic Retinopathy

Sponsor: (OSI) Eyetech

Status: Enrolling patients

Purpose: To compare the safety and efficacy of Macugen in patients with DME

Design: Phase 3, randomized, controlled, double-masked, multicenter, comparative, dose finding

Number of Patients: Planned enrollment is 900

Site(s): 41

Information: 212-824-3100


Study: Efficacy Study of Lucentis in the Treatment of Diabetic Macular Edema

Sponsor: Rocky Mountain Retina Consultants/Genentech

Purpose: To evaluate the clinical efficacy of intravitreal injections of Ranibizumab (Lucentis) in the treatment of DME as compared to grid/focal laser

Design: Treatment, randomized, open-label, active control, parallel assignment, efficacy study

Number of Patients: 60

Inclusion Criteria: Clinically significant diabetic macular edema (CSME) or clinically significant diabetic macular edema with center involvement (CSME-CI) as defined by the ETDRS Trial (ETDRS Research Group 1987 and 1991); retinal thickening within 500 mm of the center of the fovea; hard exudates within
500 mm of the center of the fovea (if associated with adjacent retinal thickening, which may be outside of 500 μm limit); area of macular edema greater than 1 disc area but within 1 disc diameter of the center of the macula; age >21 years; visual acuity < 20/320 with definite retinal thickening due to diabetic macular edema based on clinical exam; retinal thickness on OCT measuring 250 μm or more in the central subfield or 350 μm of more in any non-central subfield; media clarity and pupillary dilatation, patient cooperation, and adequate fundus photographs and OCT will be obtainable; no other ocular conditions that could cause macular edema will be present

Exclusion Criteria: IOP exceeds 25 mm Hg; pregnancy or premenopausal women not using birth control; current treatment of a systemic infection; evidence of significant uncontrolled concomitant diseases such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders; history of recurrent significant infections or bacterial infections

Information: (801) 264-4444


VEIN OCCLUSION

Study: The Standard Care vs COrticosteroid for REtinal Vein Occlusion (SCORE) Study

Sponsor: National Eye Institute/National Institutes of Health/Department of Health and Human Services

Status: Enrollment began in October 2004

Purpose: To compare the effectiveness and safety of standard care to intravitreal injection(s) of triamcinolone for treating macular edema (swelling of the central part of the retina) associated with CRVO and BRVO

Design: Multicenter, randomized, phase 3 trial. Eligible patients within each of these 2 disease entities are randomized in a 1:1:1 ratio to 1 of 3 groups: standard care, intravitreal injection(s) of 4 mg of triamcinolone acetonide, or intravitreal injection(s) of 1 mg of triamcinolone acetonide. Enrolled patients are followed for 3 years. The preparation of triamcinolone acetonide used in the study is specially made for injection into the eye and does not contain any preservatives

Inclusion/Exclusion Criteria: Participants with macular edema associated with CRVO and BRVO who are 18 years of age or older and are willing to provide consent. Detailed inclusion/exclusion criteria are available on the SCORE Web site at http://spitfire.emmes.com/
study/score

Number of Patients: 1260; 630 with CRVO and 630 with BRVO

Site(s): 27

Information: (301) 251-1161


Study: Evaluation of Macugen Treatment of Macular Edema Due to Branch Retinal Vein Occlusion

Sponsor: Palmetto Retina Center, LLC/Pfizer/Eyetech Pharmaceuticals

Status: Enrolling patients

Purpose: To evaluate the effect of intravitreal injections of Macugen every 6 weeks for the treatment of macular edema secondary to branch retinal vein occlusion (BRVO). We hypothesize that macular edema secondary to BRVO is mediated by VEGF 165 and that chronic suppression of VEGF 165 will successfully treat BRVO related macular edema.

Number of Patients: 30

Inclusion Criteria: Macular edema secondary to BRVO involving the foveal center in male or female patients at least 18 years of age; duration of BRVO macular edema less than 6 months prior to baseline visit; best corrected ETDRS visual acuity 20/40-20/320 (Snellen equivalent) using the 4 meters testing method; central foveal thickness greater than or equal to 250 μm using the OCT-3; less than 25% of foveal capillary ring disruption and less than 2 disc areas of capillary non-perfusion within 1000 μm of the foveal center; absence of hemorrhage or lipid in the foveal center

Exclusion Criteria: Ocular conditions other than BRVO related macular edema; intraocular surgery within past
3 months; significant enlargement of foveal avascular zone (>25% disruption of capillary ring) or greater than 2 disc areas of nonperfusion within 1000 μm of foveal center; likelihood of evidence driven indication for peripheral photocoagulation in the next 6 months; evidence of spontaneous improvement within the preceding 3 months, as determined by an improvement of >15 letters of vision or thinning of the Center Point on OCT of >20% from baseline determination; prior grid laser within 4 months of baseline or more than one prior grid laser treatment; prior intravitreous or periocular steroid injections in the study eye.

Information: (803) 931-0077


COMPLETED TRIALS

Study: Macugen for Macular Edema Associated With CRVO

Sponsor: OSI/Eyetech/Pfizer

Number of Patients: 90

Information: (212) 824-3204

Results: Available at http://www.visionconnection.org/Content/ForProfessionals/News/MacugenandMacularEdema.htm



Retinal Physician, Issue: January 2007