Clinical trials are sets of tests in medical research and drug development that generate safety and efficacy data (or more specifically, information about adverse drug reactions and adverse effects of other treatments) for health interventions (e.g., drugs, diagnostics, devices, therapy protocols). They are conducted only after satisfactory information has been gathered on the quality of the nonclinical safety, and health authority/ethics committee approval is granted in the country where approval of the drug or device is sought. Previously, many emerging countries did not require local trials for product approvals. Now, though emerging countries still accept data from U.S./Europe, they also require some local trials.

Depending on the type of product and the stage of its development, investigators initially enroll volunteers and/or patients into small pilot studies, and subsequently conduct larger scale studies in patients that often compare the new product with others already approved for the affliction of interest. As positive safety and efficacy data are gathered, the number of patients is typically increased. Clinical trials can vary in size, and can involve a single research entity in one country or many such entities in multiple countries.

  1. Eyetech, EOP1004 – A Phase II/III Randomized, Double-Masked, Controlled, Dose-Ranging, Multi-Center Comparative Trial, in Parallel Groups, to Establish the Safety and Efficacy of Intravitreal Injections of EYE001 (Anti-VBEGF Pegylated Aptamer) Given Every 6 Weeks for 54 Weeks, to Patients With Exudative Age-Related Macular Degeneration (AMD).
  2. Eyetech, EOP1005 – A Phase II Randomized, Controlled, Double-Masked, Dose-Finding, Multi-Center, Comparative Trial, In Parallel Groups, to Establish the Safety and Preliminary Efficacy of Intravitreal Injections of Eye001 (Anti-VEGF Pegylated Aptamer), Given Every 6 Weeks for 12 to 30 Weeks to Patients with Clinically Significant Diabetic Macular Edema (CSME) Involving the Center of the Macula.
  3. Eyetech, EOP1006 - A Randomized, Double-Masked, Multi-Center Trial of the Safety, Tolerability and Pharmacokinetics of 1 mg/eye and 3 mg/eye Intravitreal Injections of Pegaptanib Sodium (Anti-VEGF Pegylated Aptamer) Given Every 6 Weeks for 54 Weeks, In Patients With Exudative Age-Related Macular Degeneration (AMD).
  4. Eyetech, EOP1010 – An Open-Label, Non-Comparative Protocol for the Use ofPegaptanib Sodium Injections Every 6 Weeks in Patients with Exudative Age- Related Macular Degeneration (AMD).
  5. Eyetech, EOP1011 – A Phase II Randomized, Dose-Ranging, Double-Masked, Multi-Center Trial in -Parallel Groups to Determine the Safety, Efficacy andPharmacokinetics of Intravitreous Injections of Pegaptanib Sodium Compared to Sham Injections for 30 Weeks in Patients with Recent Vision Loss Due to Macular Edema Secondary to CRVO.
  6. (OSI) Eyetech, EOP1023 – A Phase IV, Open Label, Multi-Center Trial of Maintenance Intravitreous Injections of Macugen® (Pegaptanib Sodium) Given Every 6 Weeks for 48 weeks in Subjects with Subfoveal Neovascular Age- Related Macular Degeneration (AMD) Initially Treated with a Modality Resulting in Maculopathy Improvement. (Level Study)
  7. Pfizer, Protocol A4321001 -  A Phase 1/2, Randomized, Masked, Single andMultiple-Dose, Sequential Dose-Escalation Study of the Safety and Efficacy of AG-013958 in Subjections with Subfoveal Choroidal Neovascularization Associated with Age-related Macular Degeneration.
  8. Genaera, MSI-1256F – A Phase 3 Multi-Center, Randomized, Double-Masked,Controlled Study of Squalamine Lactate (MSI01256F) for Injection for the Treatment of Subfoveal Choroidal Neovascularization Associated with Age- Related Macular Degeneration.
  9. Pfizer, Open Label Macugen for the treatment of Macular Edema Secondary to Branch Retinal Vein Occlusion (BRVO)
  10. Regeneron, Protocol VGFT-OD-0603 – A Trial to Assess the Safety and   Tolerability of Repeated Doses of Intravitreal Administration of Two VEGF TrapFormulations in Subjects with Neovascular Age Related Macular Degeneration (Phase II).
  11. Regeneron, Protocol VGFT-OD-0605 – A Randomized, Double Masked, ActiveControlled Phase III Study of the Efficacy, Safety, and Tolerability of Repeated Doses of Intravitreal VEGF Trap in Subjects with Neovascular Age-Related Macular Degeneration. (Phase III)
  12. Ophthotech, Protocol OHP1000 – A Phase I, Ascending Dose and Parallel GroupTrial to Establish the Safety, Tolerability and Pharmacokinetic Profile of Intravitreous Injections of E10030 (anti-PDGF pegylated aptamer) Given in Combination with Lucentis® 0.5 mg/eye in Subjects with Neovascular Age-Related Macular Degeneration.
  13. Ophthotech, Protocol OPH2000 – A Phase I, Ascending Dose and Parallel GroupTrial to Establish the Safety, Tolerability and Pharmacokinetic Profile of Multiple Intravitreous Injections of ARC1905 (anti-C5 aptamer) Given in Combinationwith Multiple Doses of Lucentis® 0.5 mg/eye in Subjects with Neovascular Age-Related Macular Degeneration.
  14. Genentech, Protocol FVF4165g – A Phase III, Multicenter, Randomized, ShamInjection-Controlled Study of the Efficacy and Safety of Ranibizumab InjectionCompared with Sham in Subjects with Macular Edema Secondary to Branch Retinal Vein Occlusion.
  15. Genentech, Protocol FVf4166g – A Phase III, Multicenter, Randomized, ShamInjection-Controlled Study of the Efficacy and Safety of Ranibizumab InjectionCompared with Sham in Subjects with Macular Edema Secondary to Central Retinal Vein Occlusion.
  16. Genentech, Protocol FVF3426g – An Open-Label, Multicenter Extension Study to Evaluate the Safety and Tolerability of Ranibizumab in Subjects with Choroidal Neovascularization (CNV) Secondary to Age-Related Macular   Degeneration (AMD) or Macular Edema Secondary to Retinal Vein Occlusion (RVO) Who have Completed a Genentech-Sponsored Ranibizumab Study.
  17. Genentech, Protocol FVF4579g – A Phase III, Double-Masked, Multicenter,Randomized, Active Treatment-Controlled Study of the Efficacy and Safety of 0.5 mg and 2.0 mg Ranibizumab Administered Monthly or on an As-Needed Basis (PRN) in Patients with Subfoveal Neovascular Age-Related Macular Degeneration.
  18. Regeneron, Protocol VGFT-OD-0819 – A Randomized, Double Masked, Controlled Phase III Study of the Efficacy, Safety, and Tolerability of Repeated Intravitreal Administration of VEGF Trap-Eye in Subjects with Macular Edema Secondary to Central Retinal Vein Occlusion. (CRVO).
  19. Regeneron, Protocol VGFT-OD-0910 – An Open-label, Long-term, Safety and Tolerability Extension Study of Intravitreal VEGF Trap-Eye in Neovascular Age-Related Macular Degeneration.
  20. Genentech, Protocol FVF4967g Shore – A Multicenter Randomized Study Evaluating Dosing Regimens for Treatment With Intravitreal Ranibizumab Injections in Subjects with Macular Edema Following Retinal Vein Occluson.
  21. Regeneron, Protocol VGFTe-RVO-1027 Vibrant - A Randomized, Double Masked, Multicenter, Active-Controlled Study of the Efficacy, safety, and Tolerability of 2.0 mg VEGF Trap-Eye (Aflibercept) injection compared to laser treatment in subjects with Macular Edema Secondary to Branch Retinal Vein Occlusion (BRVO).
  22. Ohr, Protocol OHR-002 - A Phase 2 study of the Efficacy an Safety of Squalamine Lactate Ophthalmic Solution 0.2% twice daily after an initial injection of Ranibizumab in Subjects with Neovascular Age-Related Macular Degeneration.
  23. Ohr, Protocol OHR-004 - Open Label Study of the Efficacy and Safety of Squalamine Lactate Ophthalmic Solution 0.2% twice daily in Subjects with Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO) and Branch Retinal Vein Occlusion (BRVO).