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Phase I Study of Corticosteroid Treatment of Ill-defined Choroidal Neovascularization in Age-related Macular Degeneration Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Phase I Study of Corticosteroid Treatment of Ill-defined Choroidal Neovascularization in Age-related Macular Degeneration conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Phase I Study of Corticosteroid Treatment of Ill-defined Choroidal Neovascularization in Age-related Macular Degeneration Clinical research trials and Phase I Study of Corticosteroid Treatment of Ill-defined Choroidal Neovascularization in Age-related Macular Degeneration medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Phase I Study of Corticosteroid Treatment of Ill-defined Choroidal Neovascularization in Age-related Macular Degeneration. Phase I Study of Corticosteroid Treatment of Ill-defined Choroidal Neovascularization in Age-related Macular Degeneration Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Phase I Study of Corticosteroid Treatment of Ill-defined Choroidal Neovascularization in Age-related Macular Degeneration clinical trial. Participants oftentimes recieve the finest healthcare available for their Phase I Study of Corticosteroid Treatment of Ill-defined Choroidal Neovascularization in Age-related Macular Degeneration condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Phase I Study of Corticosteroid Treatment of Ill-defined Choroidal Neovascularization in Age-related Macular Degeneration  Phase I Study of Corticosteroid Treatment of Ill-defined Choroidal Neovascularization in Age-related Macular Degeneration
Phase I Study of Corticosteroid Treatment of Ill-defined Choroidal Neovascularization in Age-related Macular Degeneration
For Condition: Choroidal Neovascularization,Macular Degeneration
Status: Completed
Sponsor(s): National Eye Institute (NEI) ,
Synopsis: Age-related macular degeneration (AMD) represents the most common cause of blindness in patients over the age of 60. The major cause of vision loss in this disease is due to the development of choroidal neovascular membrane formation (CNVM). Several clinical trials have proven that eyes with "well-defined" CNVM or lesions that can be readily demarcated with fluorescein angiography can be successfully treated with laser photocoagulation. However, up to 87% of eyes present with "ill-defined" CNVM or lesions that cannot be well demarcated on fluorescein angiography and are not amenable to laser photocoagulation. No beneficial treatment for this form of choroidal neovascularization has been established. Histopathologic study has demonstrated the presence of inflammatory and reparative responses in the retina of patients with ill-defined choroidal neovascularization. Since corticosteroids have been shown to downregulate many of the cellular factors involved in both inflammation and repair, the present study is designed to assess the ability of corticosteroid injection around the eye to prevent severe vision loss associated with "ill-defined" choroidal neovascularization in the setting of age-related macular degeneration. The study will be organized as a randomized open label control clinical trial involving 2 phases. Phase 1 involving 40 patients will establish the feasibility and safety of this treatment modality. Phase 2 will place emphasis on efficacy of the study.
Details: Age-related macular degeneration (AMD) represents the most common cause of blindness in patients over the age of 60. The major cause of vision loss in this disease is due to the development of choroidal neovascular membrane formation (CNVM). Several clinical trials have proven that eyes with "well-defined" CNVM or lesions that can be readily demarcated with fluorescein angiography can be successfully treated with laser photocoagulation. However, up to 87% of eyes present with "ill-defined" CNVM or lesions that cannot be well demarcated on fluorescein angiography and are not amenable to laser photocoagulation. No beneficial treatment for this form of choroidal neovascularization has been established. Histopathologic study has demonstrated the presence of inflammatory and reparative responses in the retina of patients with ill-defined choroidal neovascularization. Since corticosteroids have been shown to downregulate many of the cellular factors involved in both inflammation and repair, the present study is designed to assess the ability of corticosteroid injection around the eye to prevent severe vision loss associated with "ill-defined" choroidal neovascularization in the setting of age-related macular degeneration. The study will be organized as a randomized open label control clinical trial involving 2 phases. Phase 1 involving 40 patients will establish the feasibility and safety of this treatment modality. Phase 2 will place emphasis on efficacy of the study.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Diagnosis of AMD defined by the presence of drusen in one eye and age over 50. Vision 20/400 or worse in the fellow eye due to exudative complications from CNVM under the fovea. Visual acuity of 20/80 - 20/200 in the study eye. Ineligibility for a clinically proven laser photocoagulation protocol. No patients with age less than 50. No patients with previous laser therapy for surgery for choroidal neovascularization in the study eye. No patients with choroidal neovascularization, in the study eye, associated with other ocular diseases such as pathologic myopia, ocular histoplasmosis, posterior uveitis, idiopathic, etc. No patients with presence of geographic atrophy or serous pigment epithelial detachment under the fovea in the study eye. No patients with decreased vision, in the study eye, due to retinal disease not attributable to ill-defined CNVM, such as serous retinal pigment epithelial detachment, nonexudative form of ARM, geographic atrophy, inherited retinal dystrophy, uveitis, epiretinal membrane and others. No patients with decreased vision, in the study eye, due to significant media opacity such as corneal disease or cataract. No patients with systemic or local therapy that may alter the natural course of ill-defined CNVM, especially antiangiogenic treatment with thalidomide or alpha interferon. No patients with intraocular pressure greater than or equal to 26 or history suggesting glaucoma (e.g., history of the diagnosis of glaucoma, past or present use of medications to control intraocular pressure, or disc/nerve fiber layer defects suggestive of glaucoma) and glaucomatous visual field defects as documented by Goldmann or Humphrey perimetry taken within 6 months to qualification. No patients with any contraindications to performing the necessary diagnostic studies, especially the use of fluorescein angiography. No patients with known history of untoward complications from corticosteroid therapy, including elevated intraocular pressure in response to topical or periocular corticosteroids. No patients with medical problems which make consistent follow-up over the treatment period unlikely (e.g., stroke, severe MI, terminal carcinoma. No patients with current use of or likely need for systemic or ocular medications known to be toxic to the lens, retina or optic nerve, such as: Deferoxamine, Chloroquine/Hydrochloroquine (Plaquinil), Tamoxifen, Chlorpromazine, Phenothiazines, Ethambutol, Ocular or systemic steroids or use of steroid-containing inhalers or nasal sprays utilized more than 6 days a month on average-any regular use of pills containing steroids.
Total Enrollment: 180
Location and Contact Information:
National Eye Institute (NEI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 970151; 97-EI-0151
Study Start Date: July 21, 1997
Record last reviewed: May 3, 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001615
Other Choroidal Neovascularization Studies:
1. Phase I Study of Corticosteroid Treatment of Ill-defined Choroidal Neovascularization in Age-related Macular Degeneration
2. Fluocinolone Implant to Treat Macular Degeneration
3. Macular Photocoagulation Study (MPS)
Related Studies:
Other Choroidal Neovascularization Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Phase I Study of Corticosteroid Treatment of Ill-defined Choroidal Neovascularization in Age-related Macular Degeneration
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