ClinicalTrials.gg
CompletedNCT00555594Updated Aug 1, 2024

Prospective Study to Determine the Effect of Subconjunctival Bevacizumab (AVASTIN) in Corneal Neovascularization

A Phase 2/3 interventional study of Bevacizumab (Avastin) in Corneal Neovascularization, sponsored by Asociación para Evitar la Ceguera en México. Completed at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-01.

Sponsored by Asociación para Evitar la Ceguera en México · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Sep 2006, registered Nov 2007).
Phase
Phase 2/3
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 10 studies testing bevacizumab in Corneal Neovascularization — 1 open to participants now, 1 under way, none of them phase 3. Bevacizumab · Corneal Neovascularization.

Enrollment
7th of 10
18 · median 24
Started
2006
with 1 other
Phase 2/3
Only one
of the 10
Registered
3rd of 10
by date
Lead sponsor
1 of 10
Asociación para Evitar la Ceguera en México

Among the 10 studies testing bevacizumab in Corneal Neovascularization, this one is the 7th largest by enrollment, is one of 2 that started in 2006, is the only one in phase 2/3, and was the 3rd registered.

Corneal Neovascularization

29 studies on the registry are indexed under Corneal Neovascularization; 4 are open to participants now.

Browse Corneal Neovascularization studies →

Open to participants now

1 of the 10 studies testing bevacizumab in Corneal Neovascularization is open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

About bevacizumab

Bevacizumab: first FDA approval 2004 (AVASTIN), first EMA approval 2005. What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 3 Corneal Neovascularization studies recruiting now, 3 (100%) set no upper age limit and 0 (0%) stop at 75 or younger; 0 take children under 18; 0 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 10 studies testing bevacizumab in Corneal Neovascularization, or all of them as a file.
02

Study summary

To determine the effect of subconjunctival Bevacizumab in corneal neovascularization

Read the detailed description

Corneal transplantation is the most commonly performed transplant surgery in the world today. Immunologic rejection is the leading cause of graft failure, with about 25% of graft recipients experiencing at least one episode of rejection. Of these episodes, about 20% are irreversible. The rate of corneal graft rejection in high-risk eyes, such as corneal neovascularization, has been reported to be 50% to 70%. Vascularized corneas have a much higher rate of graft rejection than avascular corneas. Whereas the normal cornea is devoid of blood and lymphatic vessels, both can invade the cornea secondary to a variety of corneal diseases and after surgery. This not only reduces visual acuity, but also renders such a cornea high-risk, if subsequent corneal transplantation is performed.Anti-angiogenesis, the pharmacologic inhibition of new blood vessel growth and formation, is a new treatment strategy under active and vigorous investigation. Multiple growth factors have been shown to contribute to the molecular events involved in the regulation of blood vessel growth Similarly, it is assumed that angiogenic growth factors such as vascular endothelial growth factor (VEGF), considered a major pro-angiogenic factor, could play a role in the pathogenesis of neovascularization.

Several approaches can be taken to neutralize VEGF. Bevacizumab (Avastin) is a full-length humanized murine monoclonal antibody against the VEGF molecule.It binds to and inhibits the biologic activity of human VEGF preventing the interaction of this molecule to its receptors on the surface of endothelial cells. The interaction of VEGF with its receptors leads to endothelial cell proliferation and new vessel formation.

There is evidence that triamcinolone acetonide (TA) inhibits vasogenic edema and inflammation, decreases vascular leakage, reduces the secretion of VEGF by pigment epithelial cells during oxidative stress and, down-regulates the expression of the VEGF gene in vascular smooth muscle cells Furthermore, TA decreases the paracellular permeability of cultured epithelial cells and down-regulates the inflammatory expression of endothelial adhesion molecules.

03

Conditions studied

  • Corneal Neovascularization

Keywords

  • corneal neovascularization
  • Bevacizumab (Avastin)
  • Immunologic rejection
  • vascular endothelial growth factor
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Presence of vessels in minimum one quadrant
  2. vessels that penetrate more than 0.5 mm of the limb, in any depth
  3. who had signed the
  4. those that could attend to frequent ophthalmologic revisions after treatment and could wait for 6 months before the surgical procedure.

Exclusion criteria

Exclusion Criteria:

  1. Patients with urgent need of a penetrating keratoplasty, pregnancy or lactancy
  2. Patient that may need an additional procedure to penetrating keratoplasty.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
18 participants (actual)

Study arms

  • Active comparator
    A

    Patients with corneal neovascularization of infectious etiology, steroid reactors, and know glaucoma or glaucoma suspects. They received one dose of 0.1cc of subconjunctival Bevacizumab (Avastin™ Genentech, Inc, USA) in bulbar conjunctiva, 2 mm from the limbus, according to the location of the vessels.

    Drug: Bevacizumab (Avastin)

  • Active comparator
    B

    Patients with corneal neovascularization of any cause except for infectious disease. Patients of this group received one application of 0.1cc of subconjunctival Bevacizumab™ + 0.1cc of triamcinolone acetonide (ATLC; Grin laboratories, México city) in bulbar conjunctiva, 2 mm from de limbus, according to the location of the vessels.

    Drug: Bevacizumab (Avastin)

Interventions

06

What researchers measure

Primary outcomes

  1. Anterior segment slit-lamp photographs and fluorescein angiograms Compared for any sign of diminished vascularization

    Time frame: three weeks after treatment

07

Study locations

1 site
  • Asociación Para Evitar la Ceguera en México, IAP, Hospital "Dr. Luis Sánchez Bulnes"
    Mexico City, 04030, Mexico
08

References and documents

Publications

  • Foulks GN, Sanfilippo FP, Locascio JA 3rd, MacQueen JM, Dawson DV. Histocompatibility testing for keratoplasty in high-risk patients. Ophthalmology. 1983 Mar;90(3):239-44. doi: 10.1016/s0161-6420(83)34575-9. PubMed 6346199 ↗
  • Cursiefen C, Seitz B, Dana MR, Streilein JW. [Angiogenesis and lymphangiogenesis in the cornea. Pathogenesis, clinical implications and treatment options]. Ophthalmologe. 2003 Apr;100(4):292-9. doi: 10.1007/s00347-003-0798-y. German. PubMed 12682761 ↗
  • Ciardella AP, Donsoff IM, Guyer DR, Adamis A, Yannuzzi LA. Antiangiogenesis agents. Ophthalmol Clin North Am. 2002 Dec;15(4):453-8. doi: 10.1016/s0896-1549(02)00042-1. PubMed 12515077 ↗
  • Foulks GN, Sanfilippo F. Beneficial effects of histocompatibility in high-risk corneal transplantation. Am J Ophthalmol. 1982 Nov;94(5):622-9. doi: 10.1016/0002-9394(82)90007-1. PubMed 6756156 ↗
  • Norrby K. In vivo models of angiogenesis. J Cell Mol Med. 2006 Jul-Sep;10(3):588-612. doi: 10.1111/j.1582-4934.2006.tb00423.x. PubMed 16989723 ↗
  • Kuwano M, Fukushi J, Okamoto M, Nishie A, Goto H, Ishibashi T, Ono M. Angiogenesis factors. Intern Med. 2001 Jul;40(7):565-72. doi: 10.2169/internalmedicine.40.565. PubMed 11506294 ↗
  • Kvanta A, Sarman S, Fagerholm P, Seregard S, Steen B. Expression of matrix metalloproteinase-2 (MMP-2) and vascular endothelial growth factor (VEGF) in inflammation-associated corneal neovascularization. Exp Eye Res. 2000 Apr;70(4):419-28. doi: 10.1006/exer.1999.0790. PubMed 10865990 ↗
  • Gan L, Fagerholm P, Palmblad J. Vascular endothelial growth factor (VEGF) and its receptor VEGFR-2 in the regulation of corneal neovascularization and wound healing. Acta Ophthalmol Scand. 2004 Oct;82(5):557-63. doi: 10.1111/j.1600-0420.2004.00312.x. PubMed 15453853 ↗
  • Manzano RP, Peyman GA, Khan P, Carvounis PE, Kivilcim M, Ren M, Lake JC, Chevez-Barrios P. Inhibition of experimental corneal neovascularisation by bevacizumab (Avastin). Br J Ophthalmol. 2007 Jun;91(6):804-7. doi: 10.1136/bjo.2006.107912. Epub 2006 Dec 19. PubMed 17179168 ↗
  • Presta LG, Chen H, O'Connor SJ, Chisholm V, Meng YG, Krummen L, Winkler M, Ferrara N. Humanization of an anti-vascular endothelial growth factor monoclonal antibody for the therapy of solid tumors and other disorders. Cancer Res. 1997 Oct 15;57(20):4593-9. PubMed 9377574 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2006 to primary completion in Sep 2006, 0 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 7, 2007
First posted
Nov 8, 2007
StartActual
Sep 2006
Primary completionActual
Sep 2006
CompletionActual
Oct 2007
Last update
Aug 1, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00555594
Lead sponsor
Asociación para Evitar la Ceguera en México
Collaborators
National Council of Science and Technology, Mexico, Universidad Nacional Autonoma de Mexico
First posted
Nov 8, 2007
Start date
Sep 2006
Primary completion
Sep 2006
Completion
Oct 2007
Last update
Aug 1, 2024

Study contacts

Hernández-Quintela Everardo, MD
principal investigator · Consejo Nacional de Ciencia y Tecnología (CONACYT) grant no. 115755 (EHQ)

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Bevacizumab

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