Study to Evaluate Safety and Efficacy of rhNGF Eye Drops Solution Versus Vehicle in Patients With Glaucoma
Condition: Glaucoma
MeSH terms: Glaucoma
Intervention: rhNGF; Vehicle
Intervention description: Recombinant Human Nerve Growth Factor 180μg/ml (one 35 μl drop equals to 6.30 μg of rhNGF) reconstituted solution three times a day (TID) for 8 weeks of treatment.; Ophthalmic Placebo solution of the same composition as the test product with the exception of rhNGF reconstituted solution times a day (TID) for 8 weeks of treatment.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      The primary objective of the study is to assess the safety and tolerability of a 180μg/ml TID
      dose regimen of recombinant human nerve growth factor (rhNGF) eye drop solution administered
      over 8 weeks versus a vehicle control in patients with progressive primary open-angle
      glaucoma despite IOP control.

      The secondary objectives are to measure the changes in BCDVA, visual field, ERG and
      structural changes in ganglion cell layer and nerve fiber layer thickness measured by optical
      coherence tomography. The secondary outcomes will be examined at 1, 4 and 8 weeks of therapy,
      and at 4 and 24 weeks after cessation of therapy (Week 12 visit and Week 32 visit), and will
      include functional assessments to investigate evidence of a persistent biological effect
      after discontinuation of the study treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients 18 years of age or older. Participant must understand and sign the informed
             consent. If the participant's vision is impaired to the point where he/she cannot read
             the informed consent document, the document will be read to the participant in its
             entirety.

          2. Participant's clinical diagnosis must be consistent with glaucoma characterized by the
             following features: a) clinical evidence of progressive RGC dysfunction and
             degeneration using visual field and/or a structural modality. There must be at least 3
             reliable visual fields within 14 months prior to entering into the study; b) residual
             visual field preservation in at least 1 quadrant.

          3. Participant must be medically able to undergo the testing required in the flowsheet of
             exam procedures.

          4. Females of childbearing potential must agree to use an effective form of birth
             control.

        Exclusion Criteria:

          1. Participant has another optic nerve or retinal degenerative disease or co-morbidity
             causing significant vision loss, irrespective of whether it is currently treated or
             untreated, that could limit the possibility of visual recovery.

          2. Participant is blind in one eye.

          3. Participant has a requirement of acyclovir and/or related products during study
             duration. 4- Participant has evidence of corneal opacification or lack of optical
             clarity.

          4. Participant has evidence of corneal opacification or lack of optical clarity.

          5. Participant has undergone lens removal in the last 3 months, with or without
             intra-ocular lens implantation, or has undergone intra-ocular lens replacement within
             3 months, or has undergone any other ocular surgery within 9 months prior to
             initiation of study drug.

          6. Participant is receiving systemic steroids or other immunosuppressive medications.

          7. Participant is currently participating in or has within the last 3 months participated
             in any other clinical trial of a non-clinically approved drug by ocular or systemic
             administration.

          8. Participant has uveitis or other ocular inflammatory disease.

          9. Participant has diabetic macular edema.

         10. Participant has a history of ocular herpes zoster.

         11. Participant is on chemotherapy.

         12. Participant has a history of malignancy, not counting basal cell carcinomas, UNLESS it
             was treated successfully 2 years prior to inclusion in the trial.

         13. Known hypersensitivity to one of the components of the study or procedural
             medications.

         14. History of drug, medication or alcohol abuse or addiction.

         15. Females of childbearing potential (those who are not surgically sterilized or post-
             menopausal for at least 1 year) are excluded from participation in the study if they
             meet any one of the following conditions:

               1. are currently pregnant or,

               2. have a positive result on the urine pregnancy test at the Screening/Baseline
                  Visit or,

               3. intend to become pregnant during the study treatment period or,

               4. are breast-feeding or,

               5. not willing to use highly effective birth control measures, such as: Hormonal
                  contraceptives - oral, implanted, transdermal, or injected and/or mechanical
                  barrier methods - spermicide in conjunction with a barrier such as a condom or
                  diaphragm or IUD during the entire course of and 30 days after the study
                  treatment periods.