Treatment of Exudative and Vasogenic Chorioretinal Diseases Including Variants of AMD and Other CNV Related Maculopathy

Related Clinical Trial
Retrospective Case Series of Trans-scleral Cryotherapy for Retinal Hemangioblastoma 68Ga-DOTA-TOC PET/CT in Imaging Participants With Neuroendocrine Tumors Treatment of Exudative and Vasogenic Chorioretinal Diseases Including Variants of AMD and Other CNV Related Maculopathy Study of Brain and Spinal Cord Tumor Growth and Cyst Development in Patients With Von Hippel Lindau Disease Assessment of Residual VHL Function in Tumors – Can it Predict the Patients’ Individual Course of Disease? Phase II Study of Vandetanib in Individuals With Kidney Cancer A Phase 2 Study of PT2977 for the Treatment of Von Hippel Lindau Disease-Associated Renal Cell Carcinoma Drivers of Hypoxia-induced Angiogenesis in Tumor Development Evaluation of 68Gallium-DOTATATE PET/CT for Detecting Neuroendocrine Tumors MyVHL: Patient Natural History Study Metabolic Mapping to Measure Retinal Metabolism Use of Tracking Devices to Locate Abnormalities During Invasive Procedures National Eye Institute Biorepository for Retinal Diseases Evaluation of Sunitinib Malate in Patients With Von Hippel-Lindau Syndrome (VHL) Who Have VHL Lesions to Follow Pazopanib in Von Hippel-Lindau (VHL) Syndrome 17AAG to Treat Kidney Tumors in Von Hippel-Lindau Disease Effect of Vorinostat on Nervous System Hemangioblastomas in Von Hippel-Lindau Disease (Missense Mutation Only) A Phase I/II Trial for Intravitreous Treatment of Severe Ocular Von Hippel-Lindau Disease Using a Combination of the PDGF Antagonist E10030 and the VEGF Antagonist Ranibizumab Ranibizumab Injections to Treat Retinal Tumors in Patients With Von Hippel-Lindau Syndrome Screening for Endolymphatic Sac Tumours (ELSTs) in Von Hippel-Lindau (vHL) Patients Bevacizumab (Avastin) in Unresectable/Recurrent Hemangioblastoma From Von-Hippel-Lindau Disease EYE001 to Treat Retinal Tumors in Patients With Von Hippel-Lindau Syndrome Von Hippel-Lindau Disease Genetic Epidemiology Study Treatment of Von Hippel-Lindau (VHL)-Related Hemangioblastoma With PTK787/ZK 222584 TKI 258 in Von Hippel-Lindau Syndrome (VHL) Study of Sunitinib in Patients With Von Hippel-Lindau (VHL) Disease Contrast-enhanced Ultrasound as a Screening Tool for Kidney Cancer in Patients With Von-Hippel Lindau Genetic Study to Identify Gene Mutations in Participants Previously Enrolled in Clinical Trial NCI-99-C-0053 Who Have Von Hippel-Lindau Syndrome or Are at Risk for Von Hippel-Lindau Syndrome PT2385 for the Treatment of Von Hippel-Lindau Disease-Associated Clear Cell Renal Cell Carcinoma Natural History and Management of Von Hippel-Lindau (VHL) Associated Pancreatic Neuroendocrine Tumors Visualizing Vascular Endothelial Growth Factor (VEGF) Producing Lesions in Von Hippel-Lindau Disease Natural History and Management of Pancreatic Lesions in Von Hippel-Lindau Disease Sunitinib Malate to Treat Advanced Eye Disease in Patients With Von Hippel-Lindau Syndrome

Brief Title

Treatment of Exudative and Vasogenic Chorioretinal Diseases Including Variants of AMD and Other CNV Related Maculopathy

Official Title

Treatment of Exudative and Vasogenic Chorioretinal Diseases Including Variants of AMD and Other CNV Related Maculopathy With Intravitreal Injection of Lucentis (Ranibizumab Injection)

Brief Summary

      The purpose of this study is to evaluate the safety and tolerability of intravitreal
      injections of ranibizumab in the treatment of AMD variants and other choroidal
      neovascularization (CNV) related conditions (Coats' disease, idiopathic perifoveal
      telangiectasia, retinal angiomatous proliferation, polypoidal vasculopathy, pseudoxanthoma
      elasticum, pathological myopia, multi-focal choroiditis, rubeosis iridis) using the incidence
      and severity of adverse events.

      Limited forms of treatment are available that limit the loss of visual acuity. However, the
      patients may not have any substantial improvement in acuity or function. Therefore there
      remains a significant unmet need for therapeutic options managing the neovascularization and
      its consequences.

      Lucentis (ranibizumab) injection will be considered as an attempt to control the growth of
      the abnormal vessels because of evidence suggesting that angiogenic factors, such as vascular
      endothelial growth factor (VEGF), play a role in the pathogenesis of neovascular non-AMD
      conditions.

      The rationale for the study design is as follows:

      A 0.5 mg dose of Lucentis (ranibizumab), a commercially available preparation that is Food
      and Drug Administration (FDA) approved and labeled for intravitreal injection use for
      neovascular (wet) age-related macular degeneration will be used.

      In AMD variants and other CNV related conditions, vascular endothelial growth factor (VEGF)
      plays a role in the pathogenesis as in neovascular AMD.

      Intravitreal injection of ranibizumab delivers maximal concentration of the antibody fragment
      to the vitreous cavity with minimal systemic exposure. The dosing schedule, based on
      considerations of the half-life and the clinical response in patients with neovascularization
      suggests that a 1-month interval is optimal.
    


Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Safety and tolerability of intravitreal injections of ranibizumab in the treatment of non-AMD variants and other CNV related conditions

Secondary Outcome

 Mean change in central retinal thickness as measured by OCT at month 12 compared to baseline

Condition

Coats' Disease

Intervention

ranibizumab injection (0.5 mg)

Study Arms / Comparison Groups

 (Ranibizumab) Lucentis
Description:  (Ranibizumab)Lucentis 0.5%

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

18

Start Date

May 2007

Completion Date

December 2010

Primary Completion Date

December 2010

Eligibility Criteria

        Inclusion Criteria:

        Subjects will be eligible if the following criteria are met:

          1. Ability to provide written informed consent and comply with study assessments for the
             full duration of the study

          2. Age > 18 years

          3. Clinical diagnosis of the following conditions: Coats' disease, idiopathic perifoveal
             telangiectasia, retinal angiomatous proliferation, polypoidal vasculopathy,
             pseudoxanthoma elasticum, pathological myopia, multi-focal choroiditis, rubeosis
             iridis.

          4. Visual acuity of 20/40 to 20/320 in the study eye on the ETDRS visual acuity chart.

          5. Media clarity, pupillary dilation and patient cooperation sufficient to allow OCT
             testing and retinal photography

        Exclusion Criteria:

        Subjects who meet any of the following criteria will be excluded from this study:

          1. Any other condition that the investigator believes would pose a significant hazard to
             the subject if the investigational therapy is initiated

          2. Participation in another simultaneous medical investigation or trial

          3. Patient with significantly compromised visual acuity in the study eye due to
             concomitant ocular conditions.

          4. Patients who have undergone intraocular surgery within the last 2 months.

          5. Patient participating in any other investigational drug study.

          6. Use of an investigational drug or treatment related or unrelated to the patient's
             condition within 30 days prior to receipt of study medication (verteporfin,
             pegaptanib, or other AMD therapy in the study eye)

          7. Patient treated with systemic anti-VEGF or pro-VEGF agents within 3 months before
             enrollment.

          8. Previous treatment (in either eye) with intravitreal or intravenously administered
             Avastin (bevacizumab).

          9. Inability to obtain photographs to document CNV (including difficulty with venous
             access).

         10. Patient with a known adverse reaction to fluorescein dye.

         11. Patient has a history of any medical condition which would preclude scheduled visits
             or completion of the study.

         12. Patient has had insertion of scleral buckle in the study eye

         13. Patient has received radiation treatment.

         14. Aphakia or absence of the posterior capsule in the study eye. Previous violation of
             the posterior capsule in the study eye is also excluded unless as a result of yttrium
             aluminum garnet (YAG) posterior capsulotomy in association with posterior chamber lens
             implantation.

         15. Pregnancy (positive pregnancy test) or lactation.

         16. Premenopausal women not using adequate contraception. The following are considered
             effective means of contraception: surgical sterilization or use of oral
             contraceptives, barrier contraception with either a condom or diaphragm in conjunction
             with spermicidal gel, an intrauterine device (IUD), or contraceptive hormone implant
             or patch.

         17. History of glaucoma filtering surgery in the study eye.

         18. Concurrent use of more than two therapies for glaucoma.

         19. Uncontrolled glaucoma in the study eye (defined as intraocular pressure > 30 mm Hg
             despite treatment with anti-glaucoma medication)

         20. Inability to comply with study or follow-up procedure
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Lawrence A. Yannuzzi, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00470977

Organization ID

Protocol: FVF4140S


Responsible Party

Principal Investigator

Study Sponsor

Manhattan Eye, Ear & Throat Hospital

Collaborators

 Genentech, Inc.

Study Sponsor

Lawrence A. Yannuzzi, MD, Principal Investigator, LuEsther T. Mertz Retinal Research Center


Verification Date

October 2012